Stress Disorders, Post-TraumaticNCT06770998
A Study of a Novel EEG Neurofeedback System for PTSD Treatment
A study testing EEG-neurofeedback training in people with Stress Disorders, Post-Traumatic, run by Foundation for Atlanta Veterans Education and Research, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- EEG-neurofeedback training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 May 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following inclusion criteria:
- 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;
- 1-26 years from index trauma;
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- 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;
- Comorbid major depression will be allowed as long as the primary care is PTSD, because it is frequently comorbid with PTSD, and its inclusion will render our study results salient to the real-world clinical population;*
- 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).
- Note: This is a clarification that comorbid depression is allowed and not an inclusion requirement.
Who cannot join
- 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;
- 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;
- Intellectual disability (known full scale IQ<70) per the site investigator's clinical judgment;
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- 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.
- 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);
- Subjects who anticipate working during the hours of midnight to 6 AM during the study;
- Subjects with narcolepsy;
- Subjects 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 subject's medical record. However, these test results will remain part of the subject's confidential study record.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Birmingham VA Medical Center
Birmingham, Alabama, 35210
Madhavi Tamarapalli, 205-933-8101, madhavi.tamarapalli@va.gov
Lori Davis, MD
- Recruiting
Boston VA Healthcare System
Boston, Massachusetts, 02130
Site Principal Investigator, PhD, 774-826-2473, margaret_niznikiewicz@hms.harvard.edu
Caroline Johnson, (774) 826-2473, caroline.johnson6@va.gov
- Recruiting
Charleston VA Medical Center
Charleston, South Carolina, 29403
Research Coordinator, 843-829-2110 ext. x1020, samantha.laporta@va.gov
Mark Hamner, MD
- Recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
David Parker, PhD, 470-895-3242, david.a.parker@emory.edu
Erica Duncan, MD
- Recruiting
New York University Grossman School of Medicine
New York, New York, 10016
Chrissy Cho, 646-754-7454, dayeon.cho@nyulangone.org
Charles Marmar, MD
- Recruiting
University of Rochester Medical Center (URMC)
Rochester, New York, 14623
Site Principal Investigator, PhD, 585-353-3100, cacihst@rit.edu
Cory Crane, PhD
About this study
Official title: A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
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?
Read more
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
- Being tested
- EEG-neurofeedback training, Sham training
- Keywords
- EEG, trauma, neurofeedback, biofeedback, stress disorders, traumatic, trauma and stressor related disorders, military trauma, civilian trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Stress Disorders, Traumatic, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-neurofeedback trainingDevice
Also called Prism training, amyg-EFP training, active Prism training
15 training sessions (twice/week) plus two booster training sessions added to treatment as usual.
Sham trainingDevice
Also called sham Prism training
15 sham sessions (twice/week) plus two sham booster sessions added to treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Prism training | Active comparator | Not described Receives: Device: EEG-neurofeedback training |
| Sham training | Sham comparator | Not described Receives: Device: Sham training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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. Scores on the CAPS-5-R at 20 weeks after the first assessment (about one month after the second booster session) will be compared to the baseline CAPS-5-R score to determine whether the changes due to Prism training in the Prism training group vs the Sham training group persist over time.
Measured: From enrollment to 20 weeks (including an initial 8 weeks of biweekly training and two booster sessions at Week 12 and Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start14 May 2025
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- GrayMatters Health Ltd., Rochester Institute of Technology, NYU Langone Health, Atlanta VA Medical Center, Birmingham VA Health Care System, Ralph H. Johnson VA Medical Center, VA Boston Healthcare System, CTP Inc, BioStats Statistical Consulting Ltd, ShareCRF, United States Department of Defense, University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770998
- Sponsor's protocol ID
- DNC138
- Other IDs
- TP230099
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
- ClinicalTrials.gov ID
- NCT06770998
- Acronym / sponsor ID
- DNC138
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- EEG, trauma, neurofeedback, biofeedback, stress disorders, traumatic, trauma and stressor related disorders, military trauma, civilian trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.University, hospital or other
- Collaborators
- GrayMatters Health Ltd., Rochester Institute of Technology, NYU Langone Health, Atlanta VA Medical Center, Birmingham VA Health Care System, Ralph H. Johnson VA Medical Center, VA Boston Healthcare System, CTP Inc, BioStats Statistical Consulting Ltd, ShareCRF, United States Department of Defense, University of Rochester
- Study start
- 14 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism training | Active comparator | Device: EEG-neurofeedback training |
| Sham training | Sham comparator | Device: Sham training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
- 1-26 years from index trauma;
Key exclusion criteria (23 listed)
- 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.
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG-neurofeedback trainingAlso: Prism training, amyg-EFP training, active Prism training15 training sessions (twice/week) plus two booster training sessions added to treatment as usual. | Device | Prism training |
| Sham trainingAlso: sham Prism training15 sham sessions (twice/week) plus two sham booster sessions added to treatment as usual. | Device | Sham training |
Primary outcome
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)
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.
1 secondary outcome
Total CAPS-5-R score change from Baseline to Week 20
Time frame: From enrollment to 20 weeks (including an initial 8 weeks of biweekly training and two booster sessions at Week 12 and Week 16)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-neurofeedback training in people with Stress Disorders, Post-Traumatic, run by Foundation for Atlanta Veterans Education and Research, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Parker, PhD (470-895-3242, david.a.parker@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.