Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- change in cerebral oxygenation as measured by infrared spectroscopy. [ Time Frame: before and after each treatment administration ] [ Designated as safety issue: No ]
- 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 ) ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Device: 1072nm infrared light stimulation
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.
|United States, Pennsylvania|
|Plymouth Meeting, Pennsylvania, United States, 19462|
|Principal Investigator:||Marvin H Berman, Ph.D||Quietmind Foundation|