A Study of a Novel EEG Neurofeedback System for PTSD Treatment

Foundation for Atlanta Veterans Education and Research, Inc.

Status

Enrolling

Conditions

Stress Disorders, Post-Traumatic

Treatments

Device: Sham training

Device: EEG-neurofeedback training

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Industry

Identifiers

NCT06770998

TP230099 (Other Grant/Funding Number)

DNC138

Details and patient eligibility

About

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)

Enrollment

250 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of PTSD will be confirmed by reviewing medical charts and completing a structured interview, the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders (DIAMOND)
CAPS-5-R (scored as CAPS-5) total with a minimum severity score of 30 at Baseline. The CAPS-5-R is an interview that measures PTSD symptom severity.
1-20 years from index trauma (the main traumatic event, if there is one, needs to have occurred at least a year ago but no more than 20 years ago when subjects begin the study)
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
Co-occurring major depression will be allowed as long as the primary care is for PTSD, because depression frequently accompanies PTSD, and its inclusion will make our study results applicable to the real-world clinical population
Any psychotropic (potentially mind-altering) medication must have been at a stable dose for at least 4 weeks before 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, would jeopardize their ability to learn or participate)

Exclusion criteria

Completed at least one adequate course of trauma-focused behavioral therapy in the past 2 years (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
Any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) mood or anxiety disorder (in addition to those described in the previous exclusion) that is the primary focus of mental health treatment in the 6 months prior to screening, per the site investigator's clinical judgment
Lifetime diagnosis of a neurodevelopmental disorder or intellectual disability
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 (must be stopped 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
Within 3 months of beginning cognitive behavioral therapy (CBT) or any evidence-based PTSD psychotherapy, although continuing established supportive therapy will be permitted
Any significant neurological/neurosurgical history, including brain surgery or brain injury (penetrating, neurovascular, infectious, or other major brain injury), epilepsy, or other major brain abnormality or known cognitive impairment;
A history of moderate or severe traumatic brain injury (TBI) or history of 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 until week 19, but excluded if the individual is at week 20 or later in the pregnancy at Baseline; early labor in the late term of the pregnancy would require the subject to withdraw from the study.
Acute symptoms of infection with SARS-CoV-2 (COVID-19) at time of screening or 2 months prior to screening as per interview and chart review
Under criminal investigation or pending legal charges with potential incarceration
Individuals who lack stable contact information (including lack of a telephone number)
Individuals who anticipate working during the hours of midnight to 6 AM during the study
Individuals with narcolepsy
Individuals who have a Legally Authorized Representative;
A positive result on the urine toxicology screen for any illegal substance besides marijuana. (Note: if urine tests positive for any illegal substance, the results will not be included in the individual's medical record. However, these test results will remain part of the individual's confidential study record.