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 and oxygenation (CBF).

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 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.

Study locations 

Pre and post testing and treatment sessions of about 2 hours will be conducted only at Quietmind Foundation offices in Plymouth Meeting, Pa. Treatment sessions will also be provided at 2328 Pinnacle Court. Hebron, Ky.

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 to complete before and after completing the 28-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. 

Treatment program

Participants will receive up to 28 treatment sessions, once daily, seven days a week. The full evaluation process will be repeated as soon after the 28^th session as can be arranged. The 1072nm light stimulation sessions will last 15 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

On October 22, 2009, Dr. Berman and Dr. Gordon Dougal, the inventor of the 1072nm device (pictured below), presented results from the original 1072nm study at the offices of Plante & Moran, PLLC, 537 E. Pete Rose Way, Suite 200, in Cincinnati, Ohio.

4. COMPENSATION

Participants will be compensated $250 for their participation in the project. Reasonable travel expenses will also be reimbursed.

5. PROJECT FUNDING AND SUPPORT

Donations by participants and the general public will be gratefully accepted, as this project is self-funded at this time. Acceptance into the study is independent of donor status. Additional funding is being sought to expand the number of people whom we can serve. Quietmind Foundation is a 501c3 charitable corporation, and all donations are fully tax-deductible.  

Call the Quietmind Foundation office at 610-940-0488 to discuss how you can make a donation.