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| Name | Class |
|---|---|
| Maculume Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1072nm Infrared Photobiomodulation | Active Comparator | Received treatment for dementia with transcranial 1072nm infrared light stimulation. |
|
| Placebo | Placebo Comparator | Placebo device simulated transcranial photobiomodulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1072nm infrared Photobiomodulation | Device | 1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-tx (total intervention period = 28 days) scores to be compared to baseline scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marvin H Berman, Ph.D | Quietmind Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quietmind Foundation | Plymouth Meeting | Pennsylvania | 19462 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28593105 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | received actual tx |
| FG001 | Placebo Group | received placebo tx |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | received actual tx |
| BG001 | Placebo Group | received placebo tx |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | Post-tx (total intervention period = 28 days) scores to be compared to baseline scores. |
|
Course of study, approx. 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | received actual tx | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marvin Berman, PhD | QuietMind Foundation | 610.940.0488 | marvinberman@quietmindfdn.org |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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Small placebo controlled randomized trial.
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|
| Photobiomodulation SIMULATED | Device | Device mounted and procedure followed but with no stimulation. |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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. | Mean | Full Range | units on a scale |
|
| Trail making A | The Trail Making Test (TMT) is used to investigate deficits in cognitive processing speed and executive function. Part A consists of 25 circles on a piece of paper with the numbers 1-25 in random order in the circles. The patient starts with number one and draws a line from that circle to the circle with number two, etc. to number 25. More errors indicate poorer performance. | Mean | Full Range | errors at task |
|
received placebo tx
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo Group | received placebo tx | 0 | 3 | 0 | 3 | 0 | 3 |
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| D001523 | Mental Disorders |