A Study of a Novel EEG Neurofeedback System for PTSD Treatment

NCT06770998 | Recruiting DMC FDA Device

• 2 other identifiers: DNC138TP230099
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

Brief Summary

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)

Conditions

Stress Disorders, Post-Traumatic

Keywords

EEG; trauma; neurofeedback; biofeedback; stress disorders, traumatic; trauma and stressor related disorders; military trauma; civilian trauma

Outcome Measures

Primary Outcomes (1)

• Total CAPS-5-R score change from Baseline to Week 9

  Participants will take the Clinician-Administered PTSD Scale for DSM-5 Revised (the CAPS-5-R) before beginning Prism training. The CAPS-5-R assesses PTSD symptom severity with total scores that range from 0-80, with higher scores indicating more severe symptoms. There are multiple ways to score the CAPS-5-R; this study will score the CAPS-5-R using the same 0-80 score range used on the CAPS-5 (the previous version of the same assessment) so that the results from this study can be more easily compared to results from previous studies on the Prism training system. Participants' scores on the CAPS-5-R after completing training will be compared to their pre-training scores to determine whether the Prism training group shows a greater reduction in PTSD symptoms than the Sham training group.

  From enrollment to the end of 8 weeks' training (twice per week)

Secondary Outcomes (1)

• Total CAPS-5-R score change from Baseline to Week 20

  From enrollment to 20 weeks (including an initial 8 weeks of biweekly training and two booster sessions at Week 12 and Week 16)

Other Outcomes (10)

• Exploratory outcome: change in PCL-5 score from Baseline to Week 9 and from Baseline to Week 20

  20 weeks (assessed at Week 9 and Week 20)

• Exploratory outcome: change in ACPL score from Baseline to Week 9 and from Baseline to Week 20

  20 weeks (assessed at Week 9 and Week 20)

• Exploratory outcome: change in HAM-D score from Baseline to Week 9 and from Baseline to Week 20

  20 weeks (assessed at Week 9 and Week 20)

Study Arms (2)

Prism training

ACTIVE COMPARATOR

Device: EEG-neurofeedback training

Sham training

SHAM COMPARATOR

Device: Sham training

Interventions

EEG-neurofeedback training DEVICE

15 training sessions (twice/week) plus two booster training sessions added to treatment as usual.

Also known as: Prism training, amyg-EFP training, active Prism training

Prism training

Sham training DEVICE

15 sham sessions (twice/week) plus two sham booster sessions added to treatment as usual.

Also known as: sham Prism training

Sham training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 65 (older limit to avoid those with potentially reduced brain plasticity due to age);
• Male, female, and gender-nonconforming subjects will be allowed. Sites will make efforts to enroll both male and female subjects in roughly equal proportions;
• Diagnosis of PTSD comorbidities will be confirmed by clinical chart review and structured interview with the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders (DIAMOND), a semi-structured diagnostic interview instrument for DSM-5 psychiatric disorders with good test-retest reliability (Tolin et al. 2018);
• Diagnosis of PTSD based on CAPS-5-R (scored as CAPS-5) total score with a minimum severity score of 26 at Baseline in the CAPS-5 score;
• years from index trauma;
• Ability to give signed informed consent according to the judgment of the site investigator;
• Normal or corrected-to-normal vision of at least 20/30 as per eye chart screening;
• Normal or corrected-to-normal hearing as per subject report and interview with study staff;
• Willingness and ability to adhere to the study schedule;
• Any psychotropic medication must have been at a stable dose for at least 4 weeks prior to screening;
• At the time of recruitment, patients must have no plan of changing their medication or psychotherapy during the study duration if applicable (subjects will only be dropped if significant psychotropic medication changes happen as a result of clinical instability that, in the opinion of the principal investigator (PI), would jeopardize their ability to learn or participate).

You may not qualify if:

• Potential subjects will be excluded for the following:
• Completed at least one adequate course of trauma-focused behavioral therapy in the past one (1) year without improvement in PTSD symptoms, as documented in medical records. (Subjects are ineligible if medical records do not show evidence of symptom improvement from the previous trauma focused therapy that had been conducted in the year prior to Screening); Non-response will be determined by clinical judgment and qualitative note content. If PCL-5 or CAPS-5 scores are available within 2 weeks prior to beginning treatment and within 2 weeks post-treatment, an improvement of \<10 points in PCL-5 and \<10 points in CAPS-5 will be used as a threshold indicating non-response in addition to clinical judgement.
• Note: This criterion is to avoid treatment resistant patients; such patients will be enrolled in future studies);
• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I or II disorder, psychosis not otherwise specified, or delusional disorder;
• Intellectual disability (known full scale IQ\<70) per the site investigator's clinical judgment;
• DSM-5 diagnosis of moderate or severe substance use disorder within 3 months of screening;
• Prescribed benzodiazepine which cannot be stopped for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or replaced with short-acting benzodiazepines taken only at night for sleeping;
• Any suicidal behavior in the last 6 months (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period and or current (in the last 6 months) significant suicidality (defined as Level 4+ on the C-SSRS) or current significant homicidality;
• Within 3 months of beginning cognitive behavioral therapy (CBT) or any evidence-based PTSD psychotherapy, although continuing established maintenance supportive therapy will be permitted;
• Any significant neurological/neurosurgical history, including brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality or known cognitive impairment;
• A history of moderate or severe traumatic brain injury (TBI) or history of gross structural damage on brain imaging;
• Any unstable medical condition per the investigator's clinical judgment;
• Any psychiatric hospitalization within the last 6 months;
• Enrollment in another interventional clinical study at screening or within 2 months prior to screening, or within the duration of this study;
• Pregnancy is allowed, but excluded if at week 20 or later in the pregnancy at Baseline because early labor in the late term of the pregnancy would require the subject to withdraw from the study.

Sponsors & Collaborators

• Foundation for Atlanta Veterans Education and Research, Inc.: lead
• Rochester Institute of Technology: collaborator
• NYU Langone Health: collaborator
• Atlanta VA Medical Center: collaborator
• Birmingham VA Health Care System: collaborator
• Ralph H. Johnson VA Medical Center: collaborator
• VA Boston Healthcare System: collaborator
• CTP Inc: collaborator
• BioStats Statistical Consulting Ltd: collaborator
• ShareCRF: collaborator
• United States Department of Defense: collaborator
• University of Rochester: collaborator
• GrayMatters Health Ltd.: collaborator

Study Sites (6)

Birmingham VA Medical Center

Birmingham, Alabama, 35210, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

Boston VA Healthcare System

Boston, Massachusetts, 02130, United States

RECRUITING

New York University Grossman School of Medicine

New York, New York, 10016, United States

RECRUITING

University of Rochester Medical Center (URMC)

Rochester, New York, 14623, United States

RECRUITING

Charleston VA Medical Center

Charleston, South Carolina, 29403, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

David Parker, PhD

CONTACT

470-895-3242; david.a.parker@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 13, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)