A Study of a Novel EEG Neurofeedback System for PTSD Treatment

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Foundation for Atlanta Veterans Education and Research, Inc.
Study ID
NCT06770998
Status
Recruiting
Apply to this trial

Conditions

  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • EEG-neurofeedback training — DEVICE
    15 training sessions (twice/week) plus two booster training sessions added to treatment as usual.
  • Sham training — DEVICE
    15 sham sessions (twice/week) plus two sham booster sessions added to treatment as usual.

Study Details

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)

Key Dates

Start date
May 14, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Prism training
  • Sham Comparator: Sham training

Primary Outcome Measure

Total CAPS-5-R score change from Baseline to Week 9 [ Time Frame: From enrollment to the end of 8 weeks' training (twice per week) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical CenterBirminghamAlabama35210
Madhavi Tamarapalli
[email protected]
205-933-8101
Lori Davis, MD (PRINCIPAL_INVESTIGATOR)
Atlanta VA Medical CenterDecaturGeorgia30033
David Parker, PhD
[email protected]
470-895-3242
Erica Duncan, MD (PRINCIPAL_INVESTIGATOR)
Boston VA Healthcare SystemBostonMassachusetts02130
Site Principal Investigator, PhD
[email protected]
774-826-2473
Caroline Johnson
[email protected]
(774) 826-2473
Margaret Niznikiewicz, MD (PRINCIPAL_INVESTIGATOR)
New York University Grossman School of MedicineNew YorkNew York10016
Chrissy Cho
[email protected]
646-754-7454
Charles Marmar, MD (PRINCIPAL_INVESTIGATOR)
Lenard Adler, MD (SUB_INVESTIGATOR)
University of Rochester Medical Center (URMC)RochesterNew York14623
Site Principal Investigator, PhD
[email protected]
585-353-3100
Cory Crane, PhD (PRINCIPAL_INVESTIGATOR)
Caroline Easton, PhD (SUB_INVESTIGATOR)
Charleston VA Medical CenterCharlestonSouth Carolina29403
Research Coordinator
[email protected]
843-829-2110
Mark Hamner, MD (SUB_INVESTIGATOR)
Zhewu Wang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
Birmingham VA Medical Center· Birmingham, ALAtlanta VA Medical Center· Decatur, GABoston VA Healthcare System· Boston, MANew York University Grossman School of Medicine· New York, NYUniversity of Rochester Medical Center (URMC)· Rochester, NYCharleston VA Medical Center· Charleston, SC

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