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This is a placebo-controlled study of 1072nm infrared (IR) stimulation involving 28 consecutive days of 15min. light stimulation sessions. Subjects will also be tested over a 2-day period before and after the 28 sessions of IR stimulation. We are addressing the devastating cognitive and behavioral aspects of dementia. We will be combining cerebral blood flow and EEG biofeedback training to help improve executive functions.
Watch BBC video on this study's technology http://www.youtube.com/watch?v=GgDv0PSm4Iw
1. PURPOSE OF THE STUDY
This study measures whether problems with executive functioning (including attention, working memory, strategies of learning and remembering, planning, organizing, self-monitoring, inhibition, and flexible thinking) can be effectively treated by repeated brief (6-minute) exposure to 1072nm infrared light stimulation in order to increase cerebral blood flow, oxygenation (CBF), removal of toxic proteins and brain cell regeneration.
2. DESCRIPTION OF THE PROJECT
This study involves the assessing of a new approach to improving mental functioning. Quietmind Foundation (QMF) is a research and educational foundation devoted to bringing EEG biofeedback (neurofeedback) and related technologies, like 1072nm infrared therapy, into the healthcare mainstream. We are currently studying ways to use these tools to improve cognitive and behavioral problems associated with degenerative brain disorders. Click here for a description of the project including inclusion and exclusion criteria.
Testing and treatment sessions will be conducted at Quietmind Foundation offices in Plymouth Meeting and other locations depending on recruitment response from continuing care facilities in the area. Other participating locations include residents at Watermark senior living center in Philadelphia, PA.
Enrollment and assignment to study conditions
The study will involve an evaluation of cognitive functioning and a recording of brain activity conducted by a member of the Quietmind staff, which will take 3.5 hours (over two days) to complete before and after completing the 28 daily twenty-minute session trial. Testing sessions will consist of paper and pencil testing as well as computerized neuropsychological assessments and a recording of brain activity with eyes open and closed. Subjects will be randomly assigned to active treatment and placebo groups and the providers of the treatment and evaluation functions will not know what group you are in during the study period. Click here to download the informed consent for subjects. Click here to download the informed consent for caregivers.
Participants will receive up to 28 treatment sessions, once daily, seven days a week. The full evaluation process will be repeated three days after the 28th session. The 1072nm light stimulation sessions will last 15-20 minutes including the placement and removal of the helmet and blood flow measurement headband. During the first part of the session, blood flow is measured for two minutes using the headband placed around the forehead. This device will remain in place during the infrared stimulation portion of the session. Participants will wear the infrared stimulation headset and maintain an upward gaze for the duration of the session with normal blinking and they will need to sit relatively still for the entire six-minute treatment period. The headset will be removed at this point and after another minute there will be another two-minute recording of blood flow using the headband device.
3. CLINICAL TRIAL RECRUITMENT
We are actively recruiting subjects at this time.
Participants will be reimbursed up to $250 for travel expenses.
5. PROJECT FUNDING AND SUPPORT
Additional funding is being sought to expand the number of people whom we can include in the study. Quietmind Foundation is a 501c3 charitable corporation registered with the IRS and all donations are fully tax-deductible.
Call Dr. Marvin H Berman PhD at the Quietmind Foundation office at 610-940-0488 to discuss how you can make a donation.