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
Last Update Posted : February 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Device: 1072nm infrared light stimulation||Phase 1 Phase 2|
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|
|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|
- Device: 1072nm infrared light stimulation
1072nm infrared light delivering 2.6J/sq cm over a 6 minute treatment period.
- change in cerebral oxygenation as measured by infrared spectroscopy. [ Time Frame: before and after each treatment administration ]
- changes in neuropsychological and functional behaviors as observed by the primary caregivers and the subject. [ Time Frame: pre and post treatment protocol (28 consecutive daily treatments ) ]
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|