Amyotrophic Lateral Sclerosis (ALS)HAROSNCT07233148
Healing ALS Registry Observational Study (HAROS)
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Motor Neuron Disease (MND), run by Healing Advocates Registry and Ministry at 1 site in United States.
Trial summary
This is a prospective, observational, online study of people diagnosed with ALS, MND or PLS referred to as HAROS (Healing ALS Registry Observational Study). Participants will enter information into an online ALS registry once per month, including their ALSFRS-R data, certain other symptoms, dietary intake… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND), Primary Lateral Sclerosis (PLS)
- What is being tested?
- Education about treatment options, Dietary Supplements: Vitamins, Minerals, Herbs, etc. and Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to 31 Mar 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators are studying adult non-smokers who have a diagnosis of ALS, MND or PLS, irrespective of time since diagnosis.
Who may be able to join
- Diagnosed with ALS, MND or PLS
Who cannot join
- Smokers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virtual
Park City, Utah, 84098
Healing ALS Study Administrator, 1-973-714-4621, study@healingals.org
About this study
This is a prospective, observational, online study of people diagnosed with ALS, MND or PLS referred to as HAROS (Healing ALS Registry Observational Study). Participants will enter information into an online ALS registry once per month, including their ALSFRS-R data, certain other symptoms, dietary intake, supplements, medications and other therapies, both conventional and integrative. Participants will also enter the hours spent on optional self-study and free online education. The investigators will assess the effectiveness of various therapies and education by measuring physical outcomes.
Read the detailed description
There is strong evidence that Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND) and Primary Lateral Sclerosis (PLS) are potentially reversible and NOT uniformly-fatal conditions, as reported in the literature. A 12-month 2024 retrospective, observational registry data analysis of 45 ALS patients showed that 85% did better than predicted in the peer-reviewed published literature. In fact, 20% did not lose functionality and 20% actually improved functional status over 12 months.
This prospective study seeks to enroll at least 1000 patients diagnosed with ALS, MND or PLS confirmed by their neurologist into this fully-remote, larger, observational study to see if the results of the 45-person ALS data analysis can be substantiated with a larger number of ALS, MND and PLS participants. Participants will be from the USA and other countries. In addition to that primary purpose, the investigators expect to:
- determine the efficacy of an integrative medicine approach to ALS (integrative medicine includes conventional medicine, functional medicine and other medical approaches such as acupuncture, frequency medicine and meditation)
- assess the effectiveness of self-study and integrative medicine education programs on ALS outcomes
- track data to analyze the most effective treatment protocols that ALS patients are currently engaged in and correlate with clinical outcomes
- explore and analyze possible causative factors and their treatments on outcomes using advanced data analysis
Study participants commit to updating their information monthly into the online registry for at least one year, preferably for up to 10 years. This takes approximately one hour per month. Participants choose their own treatment protocols based on their own research and input from their healthcare practitioners. Self-study and integrative medicine education is optional but encouraged. Participants in this study can join other research studies at the same time as HAROS, as long as they record in the registry all studies in which they are participating.
This study (HAROS) has the potential to improve the prognosis of patients with a diagnosis of ALS, MND or PLS when results are periodically shared about the effectiveness of various treatments and education.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND), Primary Lateral Sclerosis (PLS)
- Being tested
- Education about treatment options, Dietary Supplements: Vitamins, Minerals, Herbs, etc., Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc., Diet, various diets will be observed, Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies
- Keywords
- ALS, PLS, MND, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Motor Neuron Disease, Motor Neurone Disease
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education about treatment optionsOther
Education about treatment options and integrative therapies is optional. It is available online and is free for all study participants.
Dietary Supplements: Vitamins, Minerals, Herbs, etc.Dietary supplement
The investigators are observing type and quantity of dietary supplements, vitamins, minerals and herbs that ALS/MND/PLS patients take regularly.
Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.Behavioural
Many of those diagnosed with ALS/MND/PLS regularly engage in meditation, prayer and other behavioral protocols. These will be observed and analyzed to see if, and to what degree they affect outcomes.
Diet, various diets will be observedOther
May ALS/MND/PLS patients follow a specific diet such as ketogenic, vegetarian, gluten-free, dairy-free, and/or sugar-free. The investigators will analyze which diets are most efficacious.
Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapiesOther
Exercise, physical therapy, occupational therapy, speech therapy, sauna, massage, EMS (electro-muscular stimulation), red light therapy and other physical modalities will be observed and analyzed for effect on outcomes.
ALS medications and other medicationsDrug
Many ALS/MND/PLS patients find benefit from prescription and other drugs. These will be observed and analyzed for effect on quality of life and outcomes.
Physical and emotional supportOther
Study participants are asked to record the level of emotional and physical support they get from family members, caregivers, friends, medical professionals and members of their community. The investigators will analyze how the perceived level of emotional and physical support affect outcomes.
| Study group | Role | What they receive |
|---|---|---|
| ALS/MND less than 3 years since diagnosis | Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is less 3 years, or 36 months, as of the date they join the study. Receives: Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.; Other: Diet, various diets will be observed; Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies; Drug: ALS medications and other medications; Other: Physical and emotional support | |
| PLS less than 3 years since diagnosis | Those diagnosed with PLS, Primary Lateral Sclerosis, and time since diagnosis is less 3 years, or 36 months, as of the date they join the study. Receives: Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.; Other: Diet, various diets will be observed; Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies; Drug: ALS medications and other medications; Other: Physical and emotional support | |
| ALS/MND 3 years or greater since diagnosis | Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is 3 years or greater as of the date they join the study. Receives: Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc. | |
| PLS 3 years or greater since diagnosis. | Those diagnosed with PLS, Primary Lateral Sclerosis and time since diagnosis is 3 years or greater as of the date they join the study. Receives: Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALSFRS-R ALS Functional Rating Scale - Revised
ALS Functional Ratings Scale is a set of 12 questions, with a maximum of 4 points per question and measures physical functionality. Outcomes are measured at a point in time and range from 0 for no functionality to 48 for full functionality in all areas measured. The higher the score the better the outcome.
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
ALSSQ ALS Supplementary Questionnaire
ALS Supplementary Questionnaire (ALSSQ) is a measure of physical functionality and symptoms that are not measured in the ALSFRS-R scale. Items measured in the ALSSQ are energy level, sleep quality and quantity, pain, fasciculations, muscle cramps, mucous, mental clarity, head drop and showing emotions inappropriately. There are 18 questions, 4 points each, for a maximum of 72 points. The higher this score, the better the outcome.
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Mindset Score
Mindset is measured by questions about A) positivity, maximum 400 points, B) belief in ability to get well and mental blocks to healing, maximum 18 points, and C) a Modified PANAS (Positive and Negative Affect Schedule), maximum of 50 positive points and 50 negative points. The investigators will analyze how these measures of mindset correlate with ALS/MND/PLS outcomes.
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Secondary outcomes (22)
Weight
Body Weight is often an issue with ALS/MND/PLS patients. The investigators will observe any correlation between body weight and outcomes.
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood inflammation markers Set 1
All lab tests are optional, and ordered through the patient's physician and recorded.
Inflammation and neuroinflammation are often associated with ALS/MND/PLS. Higher inflammatory markers may be correlated with faster disease progression. The investigators will analyze how these measures correlate with ALS/MND/PLS outcomes.
NfL plasma (Neurofilament Light chain - plasma) pg/mL NfL serum (Neurofilament Light chain - serum) pg/mL Interleukin-6 pg/ml TMAO (Trimethylamine-N-Oxide) pg/mL
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood inflammation markers Set 2
All lab tests are optional, and ordered through the patient's physician and recorded.
Inflammation and neuroinflammation are often associated with ALS/MND/PLS. Higher inflammatory markers may be correlated with faster disease progression. The investigators will analyze how these measures correlate with ALS/MND/PLS outcomes.
hs-CRP (high sensitivity C-Reactive Protein) mg/dL GGT (gamma-glutamyl transferase) mg/dL
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood oxidative stress markers Set 1
All lab tests are optional, and ordered through the patient's physician. Higher oxidative stress may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Serum Ferritin measured in ng/ml
- oxLDL (oxidized LDL) measured in ng/ml
- Serum 8-OHdG (8-hydroxy-2-deoxyguanosine) measured in ng/ml
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood oxidative stress markers Set 2
All lab tests are optional, and ordered through the patient's physician. Higher oxidative stress may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Serum malondialdehyde measured in nmol/mL
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 1
All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- RBC magnesium (mg/dL)
- Ceruloplasmin (mg/dL)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 2
All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Vitamin D-25 Hydroxy (ng/mL)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 3
All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Arachidonic Acid (µg/mL)
- Alpha-Linolenic Acid (µg/mL)
- Linoleic Acid (µg/mL)
- DGLA (Dihomo-gamma-linolenic acid) (μg/mL)
- EPA (Eicosapentaenoic acid) μg/mL
- DHA (Docosahexaenoic acid) μg/mL
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 4
All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Methylmalonic acid (μmol/L)
- Serum Homocysteine (μmol/L)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 5
All lab tests are optional, and ordered through the patient's physician. Levels of essential nutrients may be associated with faster or slower disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Vitamin A Retinol (μg/dL)
- Serum Copper (μg/dL)
- Serum Zinc (μg/dL)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 1
All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Insulin, fasting (mg/dL) (higher indicates higher level of insulin resistance)
- Blood Glucose, fasting (mg/dL) (higher indicates higher level of insulin resistance)
- Triglycerides (mg/dL) (higher indicates higher level of insulin resistance)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 2
All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- HDL Cholesterol (mg/dL) (lower indicates higher level of insulin resistance)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 3
All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Fructosamine, fasting (µmol/L) (higher indicates higher level of insulin resistance)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 4
All lab tests are optional, and ordered through the patient's physician. Insulin resistance may be correlated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Hemoglobin A1C (percent) (higher indicates higher level of insulin resistance)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 1
All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher IgG indicates a higher level of infection.
- IgG to Epstein Barr Viral Capsid Antigen (U/mL))
- IgG to Epstein Barr Nuclear Antigen (U/mL)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 2
All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher titer indicates a higher level of infection.
- IgG to HHV-6 Viral Antigen (Human Herpes Virus type 6) (titer)
- IgG to Coxsackie B virus Antigen (titer)
- Poliovirus Type 1 Antibodies (titer)
- Poliovirus Type 3 Anitbodies (titer)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 3
All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate withALS/MND/PLS outcomes. The higher the marker, the higher the level of infection.
- WBC (White Blood Cells) (k/uL)
- Neutrophils (k/uL) cells per microliter in thousands
- Lymphocytes (k/uL) cells per microliter in thousands
- CD57 (k/uL) cells per microliter in thousands
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 4
All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher C4A can indicate a higher level of infection, inflammation or autoimmune conditions.
- C4A (Complement 4A) (mg/dL)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 5
All lab tests are optional, and ordered through the patient's physician. Infection markers in the blood may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes. A higher LPS can indicate bacteria from the gut entering the bloodstream because of increased intestinal permeability.
- LPS Lipopolysaccharides by Endotoxin Activity Assay (EU - Endotoxin Units)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in urine toxin markers Set 1
All lab tests are optional, and ordered through the patient's physician. Increased levels of urine toxins may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Urine aflatoxin (ppb)
- Urine gliotoxin (ppb)
- Urine trichothecene (ppb)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in urine toxin markers Set 2
All lab tests are optional, and ordered through the patient's physician. Increased levels of urine toxins may be associated with faster disease progression of ALS/MND/PLS. The investigators will analyze how a change in these measures correlate with ALS/MND/PLS outcomes.
- Urine mercury (µg/L)
- Urine lead (µg/L)
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in NfL (Neurofilament Light chain)
All lab tests are optional, and ordered through the patient's physician and recorded. NfL (lNeurofilament Light chain) can be used to assess neuronal damage with ALS/MND/PLS. A higher level of NfL often indicates a higher level of neuronal damage. The investigators will analyze how changes in NfL correlate with ALS/MND/PLS outcomes.
- NfL plasma (Neurofilament Light chain - plasma) pg/mL
- NfL serum (Neurofilament Light chain - serum) pg/mL
Measured: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start26 Jan 2026
- Primary completion5 Feb 2036 (estimated)
- Study completion31 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Healing Advocates Registry and Ministry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David K Calderwood, MD, Healing Advocates Registry and Ministry
- Investigators
- William L Cowden, MD, Principal investigator, Chair of Scientific Board of Academy of Comprehensive Integrative Medicine, Co-chair of Medical Advisory Team of Healing ALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233148
- Sponsor's protocol ID
- 25-12-299-2201
- Acronym
- HAROS
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after de-identification (text, tables, figures and appendices)
Publications
Boddy SL, Giovannelli I, Sassani M, Cooper-Knock J, Snyder MP, Segal E, Elinav E, Barker LA, Shaw PJ, McDermott CJ. The gut microbiome: a key player in the complexity of amyotrophic lateral sclerosis (ALS). BMC Med. 2021 Jan 20;19(1):13. doi: 10.1186/s12916-020-01885-3.
PubMed 33468103Peters S, Broberg K, Gallo V, Levi M, Kippler M, Vineis P, Veldink J, van den Berg L, Middleton L, Travis RC, Bergmann MM, Palli D, Grioni S, Tumino R, Elbaz A, Vlaar T, Mancini F, Kuhn T, Katzke V, Agudo A, Goni F, Gomez JH, Rodriguez-Barranco M, Merino S, Barricarte A, Trichopoulou A, Jenab M, Weiderpass E, Vermeulen R. Blood Metal Levels and Amyotrophic Lateral Sclerosis Risk: A Prospective Cohort. Ann Neurol. 2021 Jan;89(1):125-133. doi: 10.1002/ana.25932. Epub 2020 Nov 6.
PubMed 33068316Filippini T, Tesauro M, Fiore M, Malagoli C, Consonni M, Violi F, Iacuzio L, Arcolin E, Oliveri Conti G, Cristaldi A, Zuccarello P, Zucchi E, Mazzini L, Pisano F, Gagliardi I, Patti F, Mandrioli J, Ferrante M, Vinceti M. Environmental and Occupational Risk Factors of Amyotrophic Lateral Sclerosis: A Population-Based Case-Control Study. Int J Environ Res Public Health. 2020 Apr 22;17(8):2882. doi: 10.3390/ijerph17082882.
PubMed 32331298Alonso R, Pisa D, Marina AI, Morato E, Rabano A, Rodal I, Carrasco L. Evidence for fungal infection in cerebrospinal fluid and brain tissue from patients with amyotrophic lateral sclerosis. Int J Biol Sci. 2015 Apr 2;11(5):546-58. doi: 10.7150/ijbs.11084. eCollection 2015.
PubMed 25892962Fiore M, Parisio R, Filippini T, Mantione V, Platania A, Odone A, Signorelli C, Pietrini V, Mandrioli J, Teggi S, Costanzini S, Antonio C, Zuccarello P, Oliveri Conti G, Nicoletti A, Zappia M, Vinceti M, Ferrante M. Living near waterbodies as a proxy of cyanobacteria exposure and risk of amyotrophic lateral sclerosis: a population based case-control study. Environ Res. 2020 Jul;186:109530. doi: 10.1016/j.envres.2020.109530. Epub 2020 Apr 15.
PubMed 32335431Sales de Campos P, Olsen WL, Wymer JP, Smith BK. Respiratory therapies for Amyotrophic Lateral Sclerosis: A state of the art review. Chron Respir Dis. 2023 Jan-Dec;20:14799731231175915. doi: 10.1177/14799731231175915.
PubMed 37219417Li JY, Sun XH, Cai ZY, Shen DC, Yang XZ, Liu MS, Cui LY. Correlation of weight and body composition with disease progression rate in patients with amyotrophic lateral sclerosis. Sci Rep. 2022 Aug 2;12(1):13292. doi: 10.1038/s41598-022-16229-9.
PubMed 35918363Bond L, Ganguly P, Khamankar N, Mallet N, Bowen G, Green B, Mitchell CS. A Comprehensive Examination of Percutaneous Endoscopic Gastrostomy and Its Association with Amyotrophic Lateral Sclerosis Patient Outcomes. Brain Sci. 2019 Sep 4;9(9):223. doi: 10.3390/brainsci9090223.
PubMed 31487846Floeter MK, Mills R. Progression in primary lateral sclerosis: a prospective analysis. Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):339-46. doi: 10.3109/17482960903171136.
PubMed 19922121Syrow L, Calderwood D, Newton C; An Integrative Medicine approach may slow disease in ALS patients compared to standard of care: A pilot observational study. Annals of Neurology Volume 96, Number S32, 149th Annual Meeting American Neurological Association pp. S278-279 (September 2024) https://onlinelibrary.wiley.com/doi/10.1002/ana.27051
Harrison D, Mehta P, van Es MA, Stommel E, Drory VE, Nefussy B, van den Berg LH, Crayle J, Bedlack R; Pooled Resource Open-Access ALS Clinical Trials Consortium. "ALS reversals": demographics, disease characteristics, treatments, and co-morbidities. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):495-499. doi: 10.1080/21678421.2018.1457059. Epub 2018 Apr 2.
PubMed 29607695Crayle J, Lutz M, Raymond J, Mehta P, Bedlack R. Study of "ALS reversals": LifeTime environmental exposures (StARLiTE). Amyotroph Lateral Scler Frontotemporal Degener. 2023 Feb;24(1-2):54-62. doi: 10.1080/21678421.2022.2090846. Epub 2022 Jul 1.
PubMed 35775279
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing ALS Registry Observational Study (HAROS)
- ClinicalTrials.gov ID
- NCT07233148
- Acronym / sponsor ID
- HAROS / 25-12-299-2201
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND), Primary Lateral Sclerosis (PLS)
- Keywords
- ALS, PLS, MND, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Motor Neuron Disease, Motor Neurone Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Healing Advocates Registry and MinistryUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 5 Feb 2036 (estimated)
- Study completion
- 31 Mar 2036 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational, online study of people diagnosed with ALS, MND or PLS referred to as HAROS (Healing ALS Registry Observational Study). Participants will enter information into an online ALS registry once per month, including their ALSFRS-R data, certain other symptoms, dietary intake, supplements, medications and other therapies, both conventional and integrative. Participants will also enter the hours spent on optional self-study and free online education. The investigators will assess the effectiveness of various therapies and education by measuring physical outcomes.
Detailed description
There is strong evidence that Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND) and Primary Lateral Sclerosis (PLS) are potentially reversible and NOT uniformly-fatal conditions, as reported in the literature. A 12-month 2024 retrospective, observational registry data analysis of 45 ALS patients showed that 85% did better than predicted in the peer-reviewed published literature. In fact, 20% did not lose functionality and 20% actually improved functional status over 12 months.
This prospective study seeks to enroll at least 1000 patients diagnosed with ALS, MND or PLS confirmed by their neurologist into this fully-remote, larger, observational study to see if the results of the 45-person ALS data analysis can be substantiated with a larger number of ALS, MND and PLS participants. Participants will be from the USA and other countries. In addition to that primary purpose, the investigators expect to:
- determine the efficacy of an integrative medicine approach to ALS (integrative medicine includes conventional medicine, functional medicine and other medical approaches such as acupuncture, frequency medicine and meditation)
- assess the effectiveness of self-study and integrative medicine education programs on ALS outcomes
- track data to analyze the most effective treatment protocols that ALS patients are currently engaged in and correlate with clinical outcomes
- explore and analyze possible causative factors and their treatments on outcomes using advanced data analysis
Study participants commit to updating their information monthly into the online registry for at least one year, preferably for up to 10 years. This takes approximately one hour per month. Participants choose their own treatment protocols based on their own research and input from their healthcare practitioners. Self-study and integrative medicine education is optional but encouraged. Participants in this study can join other research studies at the same time as HAROS, as long as they record in the registry all studies in which they are participating.
This study (HAROS) has the potential to improve the prognosis of patients with a diagnosis of ALS, MND or PLS when results are periodically shared about the effectiveness of various treatments and education.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALS/MND less than 3 years since diagnosis | – | Other: Education about treatment options, Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc., Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc., Other: Diet, various diets will be observed, Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies, Drug: ALS medications and other medications, Other: Physical and emotional supportThose diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is less 3 years, or 36 months, as of the date they join the study. |
| PLS less than 3 years since diagnosis | – | Other: Education about treatment options, Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc., Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc., Other: Diet, various diets will be observed, Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies, Drug: ALS medications and other medications, Other: Physical and emotional supportThose diagnosed with PLS, Primary Lateral Sclerosis, and time since diagnosis is less 3 years, or 36 months, as of the date they join the study. |
| ALS/MND 3 years or greater since diagnosis | – | Other: Education about treatment options, Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc., Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is 3 years or greater as of the date they join the study. |
| PLS 3 years or greater since diagnosis. | – | Other: Education about treatment options, Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc., Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.Those diagnosed with PLS, Primary Lateral Sclerosis and time since diagnosis is 3 years or greater as of the date they join the study. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators are studying adult non-smokers who have a diagnosis of ALS, MND or PLS, irrespective of time since diagnosis.
Key inclusion criteria (1 listed)
- Diagnosed with ALS, MND or PLS
Key exclusion criteria (1 listed)
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education about treatment optionsEducation about treatment options and integrative therapies is optional. It is available online and is free for all study participants. | Other | ALS/MND 3 years or greater since diagnosis, ALS/MND less than 3 years since diagnosis, PLS 3 years or greater since diagnosis., PLS less than 3 years since diagnosis |
| Dietary Supplements: Vitamins, Minerals, Herbs, etc.The investigators are observing type and quantity of dietary supplements, vitamins, minerals and herbs that ALS/MND/PLS patients take regularly. | Dietary supplement | ALS/MND 3 years or greater since diagnosis, ALS/MND less than 3 years since diagnosis, PLS 3 years or greater since diagnosis., PLS less than 3 years since diagnosis |
| Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.Many of those diagnosed with ALS/MND/PLS regularly engage in meditation, prayer and other behavioral protocols. These will be observed and analyzed to see if, and to what degree they affect outcomes. | Behavioural | ALS/MND 3 years or greater since diagnosis, ALS/MND less than 3 years since diagnosis, PLS 3 years or greater since diagnosis., PLS less than 3 years since diagnosis |
| Diet, various diets will be observedMay ALS/MND/PLS patients follow a specific diet such as ketogenic, vegetarian, gluten-free, dairy-free, and/or sugar-free. The investigators will analyze which diets are most efficacious. | Other | ALS/MND less than 3 years since diagnosis, PLS less than 3 years since diagnosis |
| Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapiesExercise, physical therapy, occupational therapy, speech therapy, sauna, massage, EMS (electro-muscular stimulation), red light therapy and other physical modalities will be observed and analyzed for effect on outcomes. | Other | ALS/MND less than 3 years since diagnosis, PLS less than 3 years since diagnosis |
| ALS medications and other medicationsMany ALS/MND/PLS patients find benefit from prescription and other drugs. These will be observed and analyzed for effect on quality of life and outcomes. | Drug | ALS/MND less than 3 years since diagnosis, PLS less than 3 years since diagnosis |
| Physical and emotional supportStudy participants are asked to record the level of emotional and physical support they get from family members, caregivers, friends, medical professionals and members of their community. The investigators will analyze how the perceived level of emotional and physical support affect outcomes. | Other | ALS/MND less than 3 years since diagnosis, PLS less than 3 years since diagnosis |
Primary outcome
ALSFRS-R ALS Functional Rating Scale - Revised
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
ALS Functional Ratings Scale is a set of 12 questions, with a maximum of 4 points per question and measures physical functionality. Outcomes are measured at a point in time and range from 0 for no functionality to 48 for full functionality in all areas measured. The higher the score the better the outcome.
ALSSQ ALS Supplementary Questionnaire
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
ALS Supplementary Questionnaire (ALSSQ) is a measure of physical functionality and symptoms that are not measured in the ALSFRS-R scale. Items measured in the ALSSQ are energy level, sleep quality and quantity, pain, fasciculations, muscle cramps, mucous, mental clarity, head drop and showing emotions inappropriately. There are 18 questions, 4 points each, for a maximum of 72 points. The higher this score, the better the outcome.
Mindset Score
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Mindset is measured by questions about A) positivity, maximum 400 points, B) belief in ability to get well and mental blocks to healing, maximum 18 points, and C) a Modified PANAS (Positive and Negative Affect Schedule), maximum of 50 positive points and 50 negative points. The investigators will analyze how these measures of mindset correlate with ALS/MND/PLS outcomes.
22 secondary outcomes
Weight
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood inflammation markers Set 1
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood inflammation markers Set 2
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood oxidative stress markers Set 1
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood oxidative stress markers Set 2
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 1
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 2
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 3
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 4
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood essential nutrient levels Set 5
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 1
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 2
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 3
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood insulin resistance markers Set 4
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 1
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 2
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 3
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 4
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in blood infection markers Set 5
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in urine toxin markers Set 1
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in urine toxin markers Set 2
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Change in NfL (Neurofilament Light chain)
Time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 33468103Boddy SL, Giovannelli I, Sassani M, Cooper-Knock J, Snyder MP, Segal E, Elinav E, Barker LA, Shaw PJ, McDermott CJ. The gut microbiome: a key player in the complexity of amyotrophic lateral sclerosis (ALS). BMC Med. 2021 Jan 20;19(1):13. doi: 10.1186/s12916-020-01885-3.
- Background: PubMed 33068316Peters S, Broberg K, Gallo V, Levi M, Kippler M, Vineis P, Veldink J, van den Berg L, Middleton L, Travis RC, Bergmann MM, Palli D, Grioni S, Tumino R, Elbaz A, Vlaar T, Mancini F, Kuhn T, Katzke V, Agudo A, Goni F, Gomez JH, Rodriguez-Barranco M, Merino S, Barricarte A, Trichopoulou A, Jenab M, Weiderpass E, Vermeulen R. Blood Metal Levels and Amyotrophic Lateral Sclerosis Risk: A Prospective Cohort. Ann Neurol. 2021 Jan;89(1):125-133. doi: 10.1002/ana.25932. Epub 2020 Nov 6.
- Background: PubMed 32331298Filippini T, Tesauro M, Fiore M, Malagoli C, Consonni M, Violi F, Iacuzio L, Arcolin E, Oliveri Conti G, Cristaldi A, Zuccarello P, Zucchi E, Mazzini L, Pisano F, Gagliardi I, Patti F, Mandrioli J, Ferrante M, Vinceti M. Environmental and Occupational Risk Factors of Amyotrophic Lateral Sclerosis: A Population-Based Case-Control Study. Int J Environ Res Public Health. 2020 Apr 22;17(8):2882. doi: 10.3390/ijerph17082882.
- Background: PubMed 25892962Alonso R, Pisa D, Marina AI, Morato E, Rabano A, Rodal I, Carrasco L. Evidence for fungal infection in cerebrospinal fluid and brain tissue from patients with amyotrophic lateral sclerosis. Int J Biol Sci. 2015 Apr 2;11(5):546-58. doi: 10.7150/ijbs.11084. eCollection 2015.
- Background: PubMed 32335431Fiore M, Parisio R, Filippini T, Mantione V, Platania A, Odone A, Signorelli C, Pietrini V, Mandrioli J, Teggi S, Costanzini S, Antonio C, Zuccarello P, Oliveri Conti G, Nicoletti A, Zappia M, Vinceti M, Ferrante M. Living near waterbodies as a proxy of cyanobacteria exposure and risk of amyotrophic lateral sclerosis: a population based case-control study. Environ Res. 2020 Jul;186:109530. doi: 10.1016/j.envres.2020.109530. Epub 2020 Apr 15.
- Background: PubMed 37219417Sales de Campos P, Olsen WL, Wymer JP, Smith BK. Respiratory therapies for Amyotrophic Lateral Sclerosis: A state of the art review. Chron Respir Dis. 2023 Jan-Dec;20:14799731231175915. doi: 10.1177/14799731231175915.
- Background: PubMed 35918363Li JY, Sun XH, Cai ZY, Shen DC, Yang XZ, Liu MS, Cui LY. Correlation of weight and body composition with disease progression rate in patients with amyotrophic lateral sclerosis. Sci Rep. 2022 Aug 2;12(1):13292. doi: 10.1038/s41598-022-16229-9.
- Background: PubMed 31487846Bond L, Ganguly P, Khamankar N, Mallet N, Bowen G, Green B, Mitchell CS. A Comprehensive Examination of Percutaneous Endoscopic Gastrostomy and Its Association with Amyotrophic Lateral Sclerosis Patient Outcomes. Brain Sci. 2019 Sep 4;9(9):223. doi: 10.3390/brainsci9090223.
- Background: PubMed 19922121Floeter MK, Mills R. Progression in primary lateral sclerosis: a prospective analysis. Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):339-46. doi: 10.3109/17482960903171136.
- BackgroundSyrow L, Calderwood D, Newton C; An Integrative Medicine approach may slow disease in ALS patients compared to standard of care: A pilot observational study. Annals of Neurology Volume 96, Number S32, 149th Annual Meeting American Neurological Association pp. S278-279 (September 2024) https://onlinelibrary.wiley.com/doi/10.1002/ana.27051
- Background: PubMed 29607695Harrison D, Mehta P, van Es MA, Stommel E, Drory VE, Nefussy B, van den Berg LH, Crayle J, Bedlack R; Pooled Resource Open-Access ALS Clinical Trials Consortium. "ALS reversals": demographics, disease characteristics, treatments, and co-morbidities. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):495-499. doi: 10.1080/21678421.2018.1457059. Epub 2018 Apr 2.
- Background: PubMed 35775279Crayle J, Lutz M, Raymond J, Mehta P, Bedlack R. Study of "ALS reversals": LifeTime environmental exposures (StARLiTE). Amyotroph Lateral Scler Frontotemporal Degener. 2023 Feb;24(1-2):54-62. doi: 10.1080/21678421.2022.2090846. Epub 2022 Jul 1.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after de-identification (text, tables, figures and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William L Cowden, MD principal investigator
Chair of Scientific Board of Academy of Comprehensive Integrative Medicine, Co-chair of Medical Advisory Team of Healing ALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Motor Neuron Disease (MND), run by Healing Advocates Registry and Ministry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Healing ALS Study Administrator (1-973-714-4621, Study@HealingALS.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALSFRS-R ALS Functional Rating Scale - Revised (time frame: Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07233148, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.