Amyotrophic Lateral SclerosisALSEFSNCT06165172
Early Feasibility Study of the MyoRegulator® for Treatment of ALS
A study testing MyoRegulator® in people with Amyotrophic Lateral Sclerosis, run by PathMaker Neurosystems Inc. at 1 site in United States.
Trial summary
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- MyoRegulator®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- A clinical diagnosis of ALS as confirmed by medical history
- Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration
- Willing to refrain from participation in any other clinical trial for the duration of this study
- Willing to forgo pregnancy for the duration of the study
- Willing and able to give informed consent or have informed consent provided for them by their legal guardian
- Cognitive function sufficient to understand the study and follow instructions (per interview with appropriate clinician)
Who cannot join
- Study participants who are on permanent assisted ventilation (PAV) defined as >22h of noninvasive or invasive ventilation a day for > 7 consecutive days.
- Implanted intrathecal pump
- Prior botulinum toxin injection(s) within 12 weeks of study enrollment
- Prior phenol or alcohol injections within 6 months of study enrollment
- Presence of potential risk factors for trans-spinal direct current stimulation:
- Damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
Show all 12Show fewer
- Lack of sensory perception at the stimulation sites
- Presence of an electrically, magnetically, or mechanically activated implant (including cardiac pacemaker) or any other electrically sensitive support system with the exception of loop recorders
- Ferrous metal in the path of the current flow (jewelry must be removed during stimulation)
- Past history of epileptic seizures or unexplained spells of loss of consciousness during the previous 36 months
- Any medical condition that would prevent the participant from being able to participate in the clinical outcome measures
- Pregnant females, as determined by a pregnancy test at enrollment (in females of child-bearing potential)
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
About this study
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of serious adverse events related to the use of the device.
The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation. It has been used in two completed clinical trials evaluating its efficacy to treat post-stroke muscle spasticity and is currently being evaluated in a third trial in this post-stroke population.
Read the detailed description
Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease) is a progressive neurodegenerative disease that affects motor neurons in spinal cord and brain. ALS causes motor and cognitive function deficits and eventual death, typically within 2-5 years of diagnosis. There are at least 30,000 ALS patients in the United States and about 5,000 new diagnoses every year according to the Centers for Disease Control (CDC).
Recent research has established important links between ALS and motor neuron hyperexcitability and suggest that motor neuron hyperexcitability is found across different ALS variants.
The multi-site DCS MyoRegulator® treatment is a non-invasive approach to the suppression of motor neuron hyperexcitability based on multi-site direct current stimulation (DCS). Pre-clinical studies show that treatment using multi-site DCS effectively slows disease progression in transgenic mouse models of ALS. This is associated with improved motor function, preservation of motor neurons, and improved animal survival.
This clinical study is a non-significant risk (NSR) investigation using the non-invasive multi-site DCS MyoRegulator® to evaluate the feasibility and safety of treatment with MyoRegulator® in individuals with ALS. The primary endpoint is feasibility and safety. Feasibility will be evaluated by recording and assessing the proportion potential participants who are enrolled from the total number of participants screened for the study, the ease of delivering treatment, the tolerability of study participants to the treatment, and the compliance of study participants with the study schedule and evaluations. Safety will be evaluated by recording the frequency and duration of any adverse events reported by study participants or observed by physical examination during or following treatment and throughout the study duration.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- MyoRegulator®
- Keywords
- amyotrophic lateral sclerosis, neuromodulation, motor neuron hyperexcitability suppression, non-invasive
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoRegulator®Device
Study participants will receive treatment using the MyoRegulator® device 3 times a week for 2 x 30 minutes per session. The first week of treatment will be followed by a 1-week rest period with no treatments. Treatment sessions will then resume for 4 consecutive weeks, 3 times per week. A follow-up visit will be scheduled 4 weeks after the last treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Active treatment with MyoRegulator® device Receives: Device: MyoRegulator® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by number of patients with any device-related serious adverse event
Safety will be evaluated by recording the frequency, severity, and duration of any adverse events reported by study participants or observed by physical examination during or following treatment and throughout the study duration.
Measured: Up to 4 weeks following the last treatment
Tolerability as measured by patient's ability to complete the treatments
Treatment tolerability will be evaluated by assessing the ease of delivering treatment, the tolerability of study participants to the treatment, and the compliance of study participants with the study schedule and evaluations.
Measured: Up to 4 weeks following the last treatment
Secondary outcomes (3)
Improvement in Functionality
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) score following treatment as compared to baseline. The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 0 (no ability) to 4 (normal), with a summed total score from 0 (worst) to 48 (best).
Measured: Up to 4 weeks following the last treatment
Improvement in Activities of Daily Living
Change in Rasch Overall ALS Disability Scale (ROADS) score following treatment as compared to baseline.
The ROADS is a patient-reported outcome measure that assesses overall disability level in people with ALS. The scale contains 28 items, each scored 0 (unable to perform), 1 (can perform but with difficulty), or 2 (normal performance) and a summed total score from 0 (worst) to 56 (best).
Measured: Up to 4 weeks following the last treatment
Improvement in Quality of Life
Change in Amyotrophic Lateral Sclerosis Assessment Questionnaire - 40 (ALSAQ-40) score following treatment as compared to baseline. The ALSAQ-40 consists of 40 questions about how well the patient can perform tasks in 5 areas: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability with a summed total score from 0 (worst) to 40 (best).
Measured: Up to 4 weeks following the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start21 Jun 2023
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- PathMaker Neurosystems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Rehabilitation Hospital, Sean M. Healey & AMG Center for ALS, Muscular Dystrophy Association
- Responsible party
- Sponsor
- Investigators
- J. Leon Morales-Quezada, M.D, Ph.D., Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165172
- Sponsor's protocol ID
- PMN-004
- Acronym
- ALSEFS
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the MyoRegulator® for Treatment of ALS
- ClinicalTrials.gov ID
- NCT06165172
- Acronym / sponsor ID
- ALSEFS / PMN-004
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, neuromodulation, motor neuron hyperexcitability suppression, non-invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- PathMaker Neurosystems Inc.Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Rehabilitation Hospital, Sean M. Healey & AMG Center for ALS, Muscular Dystrophy Association
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 11 Dec 2023 (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 single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of serious adverse events related to the use of the device.
The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation. It has been used in two completed clinical trials evaluating its efficacy to treat post-stroke muscle spasticity and is currently being evaluated in a third trial in this post-stroke population.
Detailed description
Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease) is a progressive neurodegenerative disease that affects motor neurons in spinal cord and brain. ALS causes motor and cognitive function deficits and eventual death, typically within 2-5 years of diagnosis. There are at least 30,000 ALS patients in the United States and about 5,000 new diagnoses every year according to the Centers for Disease Control (CDC).
Recent research has established important links between ALS and motor neuron hyperexcitability and suggest that motor neuron hyperexcitability is found across different ALS variants.
The multi-site DCS MyoRegulator® treatment is a non-invasive approach to the suppression of motor neuron hyperexcitability based on multi-site direct current stimulation (DCS). Pre-clinical studies show that treatment using multi-site DCS effectively slows disease progression in transgenic mouse models of ALS. This is associated with improved motor function, preservation of motor neurons, and improved animal survival.
This clinical study is a non-significant risk (NSR) investigation using the non-invasive multi-site DCS MyoRegulator® to evaluate the feasibility and safety of treatment with MyoRegulator® in individuals with ALS. The primary endpoint is feasibility and safety. Feasibility will be evaluated by recording and assessing the proportion potential participants who are enrolled from the total number of participants screened for the study, the ease of delivering treatment, the tolerability of study participants to the treatment, and the compliance of study participants with the study schedule and evaluations. Safety will be evaluated by recording the frequency and duration of any adverse events reported by study participants or observed by physical examination during or following treatment and throughout the study duration.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: MyoRegulator®Active treatment with MyoRegulator® device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- A clinical diagnosis of ALS as confirmed by medical history
- Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration
- Willing to refrain from participation in any other clinical trial for the duration of this study
- Willing to forgo pregnancy for the duration of the study
Key exclusion criteria (12 listed)
- Study participants who are on permanent assisted ventilation (PAV) defined as >22h of noninvasive or invasive ventilation a day for > 7 consecutive days.
- Implanted intrathecal pump
- Prior botulinum toxin injection(s) within 12 weeks of study enrollment
- Prior phenol or alcohol injections within 6 months of study enrollment
- Presence of potential risk factors for trans-spinal direct current stimulation:
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 |
|---|---|---|
| MyoRegulator®Study participants will receive treatment using the MyoRegulator® device 3 times a week for 2 x 30 minutes per session. The first week of treatment will be followed by a 1-week rest period with no treatments. Treatment sessions will then resume for 4 consecutive weeks, 3 times per week. A follow-up visit will be scheduled 4 weeks after the last treatment session. | Device | Intervention |
Primary outcome
Safety as measured by number of patients with any device-related serious adverse event
Time frame: Up to 4 weeks following the last treatment
Safety will be evaluated by recording the frequency, severity, and duration of any adverse events reported by study participants or observed by physical examination during or following treatment and throughout the study duration.
Tolerability as measured by patient's ability to complete the treatments
Time frame: Up to 4 weeks following the last treatment
Treatment tolerability will be evaluated by assessing the ease of delivering treatment, the tolerability of study participants to the treatment, and the compliance of study participants with the study schedule and evaluations.
3 secondary outcomes
Improvement in Functionality
Time frame: Up to 4 weeks following the last treatment
Improvement in Activities of Daily Living
Time frame: Up to 4 weeks following the last treatment
Improvement in Quality of Life
Time frame: Up to 4 weeks following the last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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. This study is not recruiting at the moment.
J. Leon Morales-Quezada, M.D, Ph.D. principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoRegulator® in people with Amyotrophic Lateral Sclerosis, run by PathMaker Neurosystems Inc. 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 25 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by number of patients with any device-related serious adverse event (time frame: Up to 4 weeks following the last treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.