DementiaNCT01059877
Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
A study testing 1072nm infrared Photobiomodulation and Photobiomodulation SIMULATED in people with Dementia, run by Quietmind Foundation at 1 site in United States.
Trial summary
This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- 1072nm infrared Photobiomodulation and Photobiomodulation SIMULATED
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 50 - 85 years.
- Have established cognitive impairment, Mini Mental Status Examination (MMSE) score between 15- 25 (from a possible score of 30).
- Generally healthy otherwise as indicated by recent physical examination.
- Have a caregiver/informant who has cared for the patient at least 5 days a week and is willing to attend study visits and provide information about the patient.
- If taking any psychotropic medication should have been stable for the previous 3 months.
- Must have had B12, folic acid, full blood count and ferritin screen within the previous 6 months or be on B12 and/or folic acid replacement.
Who cannot join
- Uncontrolled or unstable chronic illness, e.g., hypertension, chronic obstructive pulmonary disease (COPD).
- Diagnosed actively growing intracranial pathology (tumors etc).
- An associated psychotic illness.
- Misusing illegal substances or alcohol.
- On regular systemic steroids or anti-metabolites.
- Systemic malignancies and/or space occupying lesions in the brain.
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- Not fluent in English.
- Depressed as assessed by Beck Depression Inventory score.
- Epilepsy.
- Lacking the capacity to give informed consent.
- Previous history of stroke or heart attack.
- History of aggression or violence.
- Inability to travel to the research venue for multiple assessments.
- A history of major psychiatric illness, seizure disorder, or physical illness that would compromise their participation in a daily treatment regimen.
- A participant may be disqualified if their performance is above the normative mean or below the lowest interpretable score of neuropsychological tests provided during the initial assessment (see #6, Sources of research material obtained from study participants, below).
Trial locations and contacts
1 site in 1 country.
United States1 site
Quietmind Foundation
Plymouth Meeting, Pennsylvania, 19462
About this study
Official title: Assessing the Effect of 1072nm Infrared (IR) Phototherapy on the Behavioral and Cognitive Symptoms Associated With Early and Mid-stage Dementia: a Randomized Placebo-controlled Clinical Trial.
This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia.
Read the detailed description
What hypotheses are you testing?
We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared stimulation of the cortex surface improves cognitive and behavioral functioning as indicated by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement on standardized neuropsychological measures.
Intensive near infrared stimulation has been shown to be effective in accelerating healing of injuries and functional modification including increasing blood flow and perfusion. Dementia research has suggested that hypoperfusion is a significant underlying mechanism in the progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to explore whether the increasing of regional cerebral perfusion and oxygenation using infrared light stimulation will result in improved cognitive and behavioral functioning.
- Conditions
- Dementia
- Being tested
- 1072nm infrared Photobiomodulation, Photobiomodulation SIMULATED
- Keywords
- dementia alzheimers frontotemporal lyme,, lewy body cognitive impairment
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1072nm infrared PhotobiomodulationDevice
Also called Photobiomodulation, Low-level LED Light Stimulation
1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.
Photobiomodulation SIMULATEDDevice
Device mounted and procedure followed but with no stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 1072nm Infrared Photobiomodulation | Active comparator | Received treatment for dementia with transcranial 1072nm infrared light stimulation. Receives: Device: 1072nm infrared Photobiomodulation |
| Placebo | Placebo comparator | Placebo device simulated transcranial photobiomodulation Receives: Device: Photobiomodulation SIMULATED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements.
Measured: Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Small placebo controlled randomized trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quietmind Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Maculume Ltd.
- Responsible party
- Principal investigator, Marvin H. Berman, Ph.D., Quietmind Foundation
- Investigators
- Marvin H Berman, Ph.D, Principal investigator, Quietmind Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059877
- Sponsor's protocol ID
- QMF-MID12610
- Status last verified
- Aug 2018
- First submitted
- 28 Jan 2010
- Last updated
- 27 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Berman MH, Halper JP, Nichols TW, Jarrett H, Lundy A, Huang JH. Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition. J Neurol Neurosci. 2017;8(1):176. doi: 10.21767/2171-6625.1000176. Epub 2017 Feb 28.
PubMed 28593105
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of 1072nm Infrared (IR) Phototherapy on the Behavioral and Cognitive Symptoms Associated With Early and Mid-stage Dementia: a Randomized Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01059877
- Acronym / sponsor ID
- QMF-MID12610
- Conditions
- Dementia
- Keywords
- dementia alzheimers frontotemporal lyme,, lewy body cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Quietmind FoundationUniversity, hospital or other
- Collaborators
- Maculume Ltd.
- Study start
- Jan 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 27 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia.
Detailed description
What hypotheses are you testing?
We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared stimulation of the cortex surface improves cognitive and behavioral functioning as indicated by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement on standardized neuropsychological measures.
Intensive near infrared stimulation has been shown to be effective in accelerating healing of injuries and functional modification including increasing blood flow and perfusion. Dementia research has suggested that hypoperfusion is a significant underlying mechanism in the progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to explore whether the increasing of regional cerebral perfusion and oxygenation using infrared light stimulation will result in improved cognitive and behavioral functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Small placebo controlled randomized trial.
| Arm | Type | Receives |
|---|---|---|
| 1072nm Infrared Photobiomodulation | Active comparator | Device: 1072nm infrared PhotobiomodulationReceived treatment for dementia with transcranial 1072nm infrared light stimulation. |
| Placebo | Placebo comparator | Device: Photobiomodulation SIMULATEDPlacebo device simulated transcranial photobiomodulation |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 50 - 85 years.
- Have established cognitive impairment, Mini Mental Status Examination (MMSE) score between 15- 25 (from a possible score of 30).
- Generally healthy otherwise as indicated by recent physical examination.
- Have a caregiver/informant who has cared for the patient at least 5 days a week and is willing to attend study visits and provide information about the patient.
- If taking any psychotropic medication should have been stable for the previous 3 months.
Key exclusion criteria (15 listed)
- Uncontrolled or unstable chronic illness, e.g., hypertension, chronic obstructive pulmonary disease (COPD).
- Diagnosed actively growing intracranial pathology (tumors etc).
- An associated psychotic illness.
- Misusing illegal substances or alcohol.
- On regular systemic steroids or anti-metabolites.
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 |
|---|---|---|
| 1072nm infrared PhotobiomodulationAlso: Photobiomodulation, Low-level LED Light Stimulation1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period. | Device | 1072nm Infrared Photobiomodulation |
| Photobiomodulation SIMULATEDDevice mounted and procedure followed but with no stimulation. | Device | Placebo |
Primary outcome
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
Time frame: Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.
Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28593105Berman MH, Halper JP, Nichols TW, Jarrett H, Lundy A, Huang JH. Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition. J Neurol Neurosci. 2017;8(1):176. doi: 10.21767/2171-6625.1000176. Epub 2017 Feb 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marvin H Berman, Ph.D principal investigator
Quietmind Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1072nm infrared Photobiomodulation and Photobiomodulation SIMULATED in people with Dementia, run by Quietmind Foundation 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 6 inclusion and 15 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 27 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall. (time frame: Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.). 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 NCT01059877, which also lists 1 linked publication.
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 27 Sep 2018.