EEG Neurofeedback for PTSD

Recruiting at 5 trial locations

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundation for Atlanta Veterans Education and Research, Inc.

Must not be taking: Benzodiazepines

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new brain training method called Prism can reduce PTSD symptoms in US military veterans and civilians. Prism uses neurofeedback, which monitors brain waves to help individuals learn to control brain activity better. Participants will be divided into two groups: one will receive the real Prism training, and the other will receive a placebo version for comparison. Individuals with PTSD who experienced their main traumatic event between 1 and 20 years ago and are stable on their current medications may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new PTSD treatments.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but they must be stable for at least 4 weeks before the trial starts. If you're on benzodiazepines, you need to stop them at least 2 weeks before the first training session or switch to a short-acting version for sleep.

What prior data suggests that the Prism system is safe for neurofeedback training?

Research has shown that the Prism system is generally safe for people with PTSD. In a previous study, participants underwent fifteen sessions of EEG neurofeedback, a type of brain training, using Prism. The study focused on safety and effectiveness. Initial results indicated that the treatment was well-tolerated, with most participants experiencing no serious side effects.

Further reviews and studies have demonstrated that neurofeedback can significantly reduce PTSD symptoms. This suggests that the Prism system might be a promising option. However, as with any treatment, experiences can vary. It is important to consult a doctor if there are concerns about trying new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prism System for PTSD because it introduces a new approach using EEG neurofeedback, which differs significantly from traditional treatments like therapy or medication. Unlike those treatments, which primarily focus on managing symptoms through psychological methods or chemical changes in the brain, the Prism System aims to retrain the brain's electrical activity, potentially offering a more direct and non-invasive way to address the underlying neurological patterns associated with PTSD. This novel mechanism could provide faster, more targeted relief for patients, and offers hope for those who haven’t responded well to existing options.

What evidence suggests that the Prism system is effective for reducing PTSD symptoms?

Research has shown that neurofeedback, such as the Prism system, can moderately reduce PTSD symptoms. In this trial, participants will receive either Prism training or sham training. Studies also suggest neurofeedback may help with related issues like depression and anxiety. The Prism system, specifically, has demonstrated positive effects on long-term PTSD symptoms. It uses brain signals to train the brain to regulate itself, potentially lessening PTSD symptoms. Although more research is needed, early results are promising for those dealing with PTSD. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for US military Veterans and civilians with PTSD. Participants must be able to attend two one-hour training sessions weekly for 8 weeks, plus booster sessions and interviews before, after, and one month post-training.

Inclusion Criteria

My vision is 20/30 or better, with or without glasses.

My trauma happened between 1 and 20 years ago.

I will not change my medications or therapy during the study.

Exclusion Criteria

I have a health condition that changes rapidly.

I must take benzodiazepine and cannot stop during the study.

Pregnancy beyond week 19 at Baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Prism neurofeedback training sessions twice a week for 8 weeks

8 weeks

16 visits (in-person)

Booster Sessions

Participants complete two booster training sessions one month and two months after the main training

2 months

2 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms and other outcomes

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prism System

Trial Overview The study tests the Prism EEG-neurofeedback system against sham training to see if it can reduce PTSD symptoms when added to standard treatments. The effectiveness will be measured through interviews conducted at different stages of the trial.

How Is the Trial Designed?

Group I: Prism training Active Control 1 Intervention

Group II: Sham training Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Foundation for Atlanta Veterans Education and Research, Inc.

Lead Sponsor

Trials

7

Recruited

930+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

New York University Grossman School of Medicine

Collaborator

Trials

2

Recruited

1,300+

BioStats Statistical Consulting Ltd

Collaborator

Trials

1

Recruited

250+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

GrayMatters Health Ltd.

Industry Sponsor

Trials

4

Recruited

460+

Rochester Institute of Technology

Collaborator

Trials

15

Recruited

5,500+

Ralph H. Johnson VA Medical Center

Collaborator

Trials

21

Recruited

5,700+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Birmingham VA Health Care System

Collaborator

Trials

4

Recruited

630+

Published Research Related to This Trial

EEG neurofeedback (EEG NF) is a promising non-invasive method that can help modulate brain activity related to anxiety disorders and PTSD, potentially improving symptoms of over-arousal.

While positive effects of EEG NF have been observed, the exact relationship between symptom improvement and neurophysiological changes remains uncertain due to methodological issues in existing studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback for Anxiety Disorders and Post-Traumatic Stress Disorders: A Blueprint for a Promising Brain-Based Therapy. Micoulaud-Franchi, JA., Jeunet, C., Pelissolo, A., et al.[2021]

In a pilot study involving multiply-traumatized individuals with treatment-resistant PTSD, 40 sessions of EEG biofeedback (neurofeedback) significantly reduced PTSD symptoms, with average Davidson Trauma Scale scores dropping from 69.14 to 49.26.

The neurofeedback training also led to improvements in affect regulation, as indicated by a decrease in scores on the Inventory of Altered Self-Capacities-Affect Dysregulation from 23.63 to 17.20, suggesting potential benefits beyond just PTSD symptom reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Neurofeedback for Chronic PTSD. Gapen, M., van der Kolk, BA., Hamlin, E., et al.[2018]

In a study of 52 individuals with chronic PTSD, neurofeedback (NF) training significantly reduced PTSD symptoms, with only 27.3% of NF participants still meeting PTSD criteria post-treatment compared to 68.2% in the waitlist group.

The NF training also improved affect regulation capacities, showing effect sizes comparable to established PTSD treatments, indicating its potential as a promising intervention for PTSD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Neurofeedback for Chronic PTSD. van der Kolk, BA., Hodgdon, H., Gapen, M., et al.[2023]

A single session of EEG neurofeedback training in 21 individuals with PTSD led to decreased alpha rhythm amplitude during training and a subsequent 'rebound' increase in alpha synchronization, indicating a potential homeostatic response in the brain.

This rebound effect was associated with increased feelings of calmness and enhanced connectivity in brain networks related to emotional regulation, suggesting that neurofeedback may help improve regulatory systems in individuals with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plastic modulation of PTSD resting-state networks and subjective wellbeing by EEG neurofeedback. Kluetsch, RC., Ros, T., Théberge, J., et al.[2022]

The review of five studies on alpha-theta EEG biofeedback treatment for alcoholism and PTSD raises important questions about the independence of participant samples, their clinical status before treatment, and the specific treatments they received.

By addressing these questions, the authors aim to enhance the understanding of neurofeedback efficacy, allowing for more objective testing of its claims in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regarding the database for the Peniston alpha-theta EEG biofeedback protocol. Graap, K., Freides, D.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06770998

A Study of a Novel EEG Neurofeedback System for PTSD ... The goal of this clinical trial is to learn if training with the Prism system can reduce PTSD symptoms in US military Veterans and civilians with PTSD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10515677/

Neurofeedback for post-traumatic stress disorder: systematic ... Neurofeedback (NFB) was found to have moderate beneficial effects on PTSD symptoms, and positive effects on secondary outcomes such as depression and anxiety, ...

3. psychiatrictimes.com psychiatrictimes.com/view/study-highlights-efficacy-of-prism-for-ptsd-in-alleviating-chronic-ptsd-symptoms

Study Highlights Efficacy of Prism for PTSD in Alleviating ... A study explored the efficacy of the neurofeedback therapy, Prism for PTSD, in the treatment of posttraumatic stress disorder (PTSD).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04891614

The PRISM Pilot Trial for Post-Traumatic Stress Disorder The study's primary objective is to assess the safety and effectiveness of fifteen (15) EEG-NF training sessions using the Prism software in reducing PTSD- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123006613

Amygdala-derived-EEG-fMRI-pattern neurofeedback for ... Depending upon the nature of the trauma, approximately 5–9 % of people exposed to a traumatic event will go on to develop post-traumatic stress disorder (PTSD) ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K222101.pdf

March 17, 2023 GrayMatters Health Ltd. Allison Komiyama ... GrayMatters Health performed a prospective, single arm study, open label, unblinded study to assess of the Safety and Effectiveness of Prism, as ...