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

Trial Summary

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 data supports the effectiveness of the EEG Neurofeedback treatment for PTSD?

Research shows that EEG neurofeedback can significantly reduce PTSD symptoms by improving brain rhythms, specifically alpha rhythms, which are often abnormal in PTSD patients. Studies have demonstrated that neurofeedback can lead to decreased PTSD severity and improved emotional regulation, with some patients experiencing long-term benefits. ^{1 2 3 4 5}

Is EEG neurofeedback safe for humans?

EEG neurofeedback has been used for over 30 years and is generally considered safe for humans, with studies showing its use in conditions like PTSD and anxiety without significant safety concerns. ^{1 2 3 5 6}

How is the EEG Neurofeedback treatment for PTSD different from other treatments?

EEG Neurofeedback for PTSD is unique because it uses brain-computer interaction to alter brain signals and improve mental activity, which can help reduce PTSD symptoms and improve emotional regulation. Unlike traditional therapies, it focuses on restoring brain network connectivity, offering a brain-based approach to treatment. ^{1 3 6 7 8}

What is the purpose of this trial?

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. Prism is a form of neurofeedback training that uses EEG signals to promote self-regulation of brain function. The main question this study aims to answer is: Does Prism training lead to decreased PTSD symptoms in US Veterans and civilians when used in addition to usual PTSD treatment? Researchers will compare Prism training to a sham training (a look-alike training that does not provide real feedback on brain activity) to see if Prism training decreases PTSD symptoms. Participants will: * Complete two one-hour in-person training sessions a week for about 8 weeks (15 sessions) * Complete two booster training sessions one month and two months after finishing the main training course * Participate in three detailed interviews: one before training, a second after nine weeks of training, and a third one month after the last booster training session (about 20 weeks after the initial visit)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A Pilot Study of Neurofeedback for Chronic PTSD. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Regarding the database for the Peniston alpha-theta EEG biofeedback protocol. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback for Anxiety Disorders and Post-Traumatic Stress Disorders: A Blueprint for a Promising Brain-Based Therapy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Homeostatic normalization of alpha brain rhythms within the default-mode network and reduced symptoms in post-traumatic stress disorder following a randomized controlled trial of electroencephalogram neurofeedback. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Plastic modulation of PTSD resting-state networks and subjective wellbeing by EEG neurofeedback. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Neurofeedback for Chronic PTSD. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of alpha-rhythm EEG neurofeedback in posttraumatic stress disorder: A preliminary investigation showing evidence of decreased PTSD symptoms and restored default mode and salience network connectivity using fMRI. [2023]

8. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of neurofeedback in the reduction of Posttraumatic stress disorder (PTSD) in a patient following high-voltage electric shock with the use of ERPs. [2015]