Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
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|ClinicalTrials.gov Identifier: NCT01059877|
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Device: 1072nm infrared Photobiomodulation Device: Photobiomodulation SIMULATED||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Small placebo controlled randomized trial.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Active Comparator: 1072nm Infrared Photobiomodulation
Received treatment for dementia with transcranial 1072nm infrared light stimulation.
Device: 1072nm infrared Photobiomodulation
1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.
Other Name: Photobiomodulation, Low-level LED Light Stimulation
Placebo Comparator: Placebo
Placebo device simulated transcranial photobiomodulation
Device: Photobiomodulation SIMULATED
Device mounted and procedure followed but with no stimulation.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059877
|United States, Pennsylvania|
|Plymouth Meeting, Pennsylvania, United States, 19462|
|Principal Investigator:||Marvin H Berman, Ph.D||Quietmind Foundation|