Clinical trial NCT06770998: A Study of a Novel EEG Neurofeedback System for PTSD Treatment
Official title: A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: EEG
trauma
neurofeedback
biofeedback
stress disorders, traumatic
trauma and stressor related disorders
military trauma
civilian trauma
Lead sponsor: Foundation for Atlanta Veterans Education and Research, Inc.
Sponsor class: OTHER
Collaborators: name: GrayMatters Health Ltd.
name: Rochester Institute of Technology
name: NYU Langone Health
name: Atlanta VA Medical Center
name: Birmingham VA Health Care System
name: Ralph H. Johnson VA Medical Center
name: VA Boston Healthcare System
name: CTP Inc
name: BioStats Statistical Consulting Ltd
name: ShareCRF
name: United States Department of Defense
First posted: 2025-01-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Total CAPS-5-R score change from Baseline to Week 9
timeFrame: From enrollment to the end of 8 weeks' training (twice per week)
Secondary outcomes:
measure: Total CAPS-5-R score change from Baseline to Week 20
timeFrame: 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:
measure: Exploratory outcome: change in PCL-5 score from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in ACPL score from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in HAM-D score from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in PHQ-9 scores from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in STAI score from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in GAD-7 score from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in CGI responses from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in PSQI score from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: change in ERQ scores from Baseline to Week 9 and from Baseline to Week 20
timeFrame: 20 weeks (assessed at Week 9 and Week 20)
measure: Exploratory outcome: identifying subject groups who would benefit from changes in the Prism training structure
timeFrame: 20 weeks
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Boston
country: United States
facility: Boston VA Healthcare System
state: Massachusetts
city: New York
country: United States
facility: New York University Grossman School of Medicine
state: New York
city: Rochester
country: United States
facility: Rochester Institute of Technology
state: New York
city: Charleston
country: United States
facility: Charleston VA Medical Center
state: South Carolina
Study officials:
References: