Clinical Trials

Quietmind Foundation is a leader in conducting integrative research on drug-free, noninvasive technologies and treatment methods for neurological and neuropsychiatric disorders, head trauma, and peak performance.

Clinical Trials

 

Quietmind Foundation’s research agenda is the repair, regrowth, and retraining of brain functions compromised by the full range of neuropsychiatric disorders, traumatic head injuries, and neurodegenerative disorders as well as the normal stressors of everyday life. Through our own cutting-edge research and our collaboration with colleagues around the world, we are inventing breakthrough therapeutic interventions for people struggling with Parkinson’s disease, dementia, ADD/ADHD, autism, anxiety, depression, addictions, post-concussion syndrome, PTSD, stroke, traumatic brain injury (TBI), epilepsy, and the cognitive side-effects of chemotherapy.

 

We are also focused on studying technologies that can assist already high-functioning children and adults achieve and maintain peak performance in artistic, athletic, academic, and professional endeavors. Results from over fifty years of ongoing research are constantly generating, reconfiguring, and shaping an informed baseline for ever-encompassing, proven applications for neurofeedback. These techniques allow a person to effortlessly open the mind’s “door” and enter the ‘‘zone,” raising the bar of self-actualized, permanent, mental and physical achievement.

 

  •     Anxiety and stress? Relieved
  •     Attention and focus? Heightened
  •     Perception and stamina? Enhanced
  •     Performance? Improved

 


 

Executives and human resource managers are using our research results to improve individual, team, and organizational performance issues including: conflict resolution, team selection and development, product marketing and placement, and executive development. 

 

Satellite Research Sites

Several QMF satellite research sites have also been established, funded, and maintained because of the ongoing support of local professionals and volunteers. QMF research staff provide professional overview, monitoring, and training. Participant testing, pre- and post-clinical trial, takes place regionally or in our QMF offices in Plymouth Meeting, PA. Potential participants who otherwise cannot afford or are too physically or mentally challenged to travel are now better able to participate in one of our ongoing clinical trials.

 

Lake Erie Brain Performance Institute
Applied Brain Research Foundation of Ohio
3430 Rocky River Drive Cleveland, OH 44111

 

Attn: Jean Alvarez, Ed.D., Director of Research

This group is focusing on the use of the Vielight 810nm intranasal device for insomnia and related problems associated with disordered sleep. Subjects will purchase a Vielight 810 intranasal device for $399 (regularly $499) and obtain a pre and post QEEG assessment for $200 (regularly $650). This is a single treatment only, proof of concept study with no placebo control condition.  Participants may elect to receive an 80% refund on their purchase at the end of the 90-day study period. Call Dr. Alvarez for informed consent and intake information 216-410-6335


Call 610-940-0488 to locate or create a remote clinical trial site in your area.

 

FAQ about clinical trials

 

What is a clinical trial?

A clinical trial is research using human volunteers to answer a specific health question. For example: “Does this new treatment help me remember things better?”

 

Why participate in a trial?

For eligible participants, a clinical trial can provide access to new treatments before they are commercially available while at the same time helping to advance medical knowledge.

 

Am I a candidate?

Each clinical trial includes specific inclusion criteria (factors that allow someone to participate) and exclusion criteria (factors that prevent someone from participating). The study coordinator can review the reasons why you may or may not be a good candidate for a particular study.


Call 610-940-0488 to learn more.

 

Active QMF Clinical Trials

Trial #1: Age Related Memory Impairment.

This phase I, 90-day, randomized, double-blind, placebo-controlled trial is being conducted to determine whether 1068nm infrared light stimulation can effect symptoms of age related memory impairment. Subjects receive 90 consecutive days of 5-minute sessions conducted in their own home. Participants’ EEG activity, memory and other cognitive abilities are tested before and after the 90-day trial. Placebo group subjects will receive the active treatment upon completion of the protocol. All study services are provided at no cost.  

If you or a loved one are noticing memory loss, call 610-940-0488 to learn how to participate in this clinical trial.

 

Trial #2: Effects of near infrared light therapy on Bradykinesia and gait in Parkinson's disease.

This Phase I study studies the effect of 1068nm near inrared light. Subjects will participate in 90, twice daily, 5-minute sessions of transcranial near infrared stimultaion. Neurophysiological, movement and gait testing is carried out before and after the study period. The training sessions are conducted remotely to allow subjects to participate even if they are living at a distance. 

To determine your eligibility, call Dr. Berman at 610-940-0488.

 

Trial #3: Long term (2-year) study of combining near infrared light stimulation and EEG neurofeedback training on cognitive and behavioral symptoms associated with early to mid-stage dementia. 

Based on our previous studies we now see that the combined use of near infrared light stimulation (NIRS) with EEG biofeedback is more effective in remediating cognitive and behavioral symptoms of dementia than either approach alone. The NIRS appears to stop the progression and the NFB appears to support sustained improvement and recovery of short term and procedural memory and executive functions. 

Subjects will be provided with both a near infrared light (1060-1080nm) stimulation system (NIRS) from Cognitolite along with a 2 channel EEG ampifier and neurofeedback training (NFB) software. All training will be conducted at the subjects' home. Trial activities will be monitored remotely and clinical assessments will be conducted by local qualified psychologists or at the Quietmind Foundation's offices in Pennsylvania.

The cost to participants for study related equipment is $7500/yr. 
Continued use of the NIRS and NFB equipment after the trial's completion will be on a donation basis and subjects can purchase the treatment system for $1 when FDA approval is obtained.


Contact Dr. Berman at 610-940-0488 for details.

 

Trial #4 Effect of Near Infrared Light Stimulation on Age-related Macular Degeneration

This stidy's focus is whether the NIR stimulation can slow or stop macular degeneration. This will be for those subjects with the dry type of degeneration adn not the wet variety. Subjects will receive a study device that they will use daily for 20-30minutes  on one eye only. Optometric testing will be conducted before, during and after 90-days of treatment. All study related services are provided free of charge and placebo group members will get the active treatment after they finish the placebo trial period.


 

Completed QMF Research Studies

Neurofeedback to treat ADHD & Conduct Disorder.

QMF studied the efficacy of neurofeedback with children in the public mental health system diagnosed with ADHD and conduct disorder. We showed that neurofeedback can be provided effectively in a community mental health and residential treatment context. Sponsored by Philadelphia Office of Mental Health/Mental Retardation.

 

Neurofeedback to treat Anxiety and Opiate Addiction.

QMF completed a pilot study on the effects of biofeedback on anxiety symptoms in a methadone-maintained population. Sponsored by Thomas Jefferson Medical College, Department of Psychiatry and Human Behavior.

 

Neurofeedback to treat Autistic Spectrum Disorder.

This study using neurofeedback on children with autistic disordered was carried out in a public charter school setting. Sponsored by the Philadelphia Academy Charter School.

 

Neurofeedback to treat Alzheimer’s Disease.

QMF studied the impact of EEG-driven stimulation biofeedback on the cognitive and behavioral symptoms of people struggling with early stage Alzheimer’s dementia.

Sponsored by the Helen Bader Foundation.


Neurofeedback to treat early to mid-stage Dementia, Phase I.

This first phase of a multiphase research project, studied the use of quantitative EEG(qEEG)-driven biofeedback training to reduce the symptoms of dementia and increase executive function. Subjects participated in 40 sessions of biofeedback training conducted twice weekly, with qEEG and neuropsychological testing conducted before and after the 40-session period. Results were presented at the 2009 International Conference on Alzheimer’s Disease (ICAD) in Vienna, Austria. Click here to download the poster

 

Sponsored by the Phoebe Haas Charitable Trusts.