RECRUITING

A Study of a Novel EEG Neurofeedback System for PTSD Treatment

Conditions

Stress Disorders, Post-Traumatic EEG trauma neurofeedback biofeedback stress disorders, traumatic trauma and stressor related disorders military trauma civilian trauma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers

Quick Facts

Study Start:2025-05-14

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06770998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Sidney Imes

CONTACT

470-895-3242

simes@emory.edu

Study Locations (Sites)

Birmingham VA Medical Center

Birmingham, Alabama, 35210

United States

Atlanta VA Medical Center

Decatur, Georgia, 30033

United States

Boston VA Healthcare System

Boston, Massachusetts, 02130

United States

New York University Grossman School of Medicine

New York, New York, 10016

United States

Rochester Institute of Technology

Rochester, New York, 14623

United States

Charleston VA Medical Center

Charleston, South Carolina, 29403

United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-14

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-05-14

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Stress Disorders, Post-Traumatic