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New treatment option for Stress Disorders, Post-Traumatic
Official title A Study of a Novel EEG Neurofeedback System for PTSD Treatment
ClinicalTrials.gov ID: NCT06770998
What this study is testing
- What it's testing
- 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.
- Time commitment: about 8 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people must meet the following
- Ages 18 to 65 (older limit to avoid those with potentially reduced brain plasticity due to age);
- Male, female, and gender-nonconforming people will be allowed. Sites will make efforts to enroll both male and female people in roughly equal...
- Diagnosis of PTSD comorbidities will be confirmed by clinical chart review and structured interview with the Diagnostic Interview for Anxiety, Mood...
- 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;
You likely can't join if
- Potential people 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...
- 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...
- Any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) Mood or anxiety disorder (in addition to those described in the...
- Intellectual disability (known full scale IQ\<70) per the site investigator's clinical judgment;
See the full eligibility criteria
Who can join
- people must meet the following
- Ages 18 to 65 (older limit to avoid those with potentially reduced brain plasticity due to age);
- Male, female, and gender-nonconforming people will be allowed. Sites will make efforts to enroll both male and female people 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...
- 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;
- 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 (people will only be dropped if significant psychotropic medication changes...
- Note: This is a clarification that comorbid depression is allowed and not an inclusion requirement.
What rules you out
- Potential people 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. (people are ineligible if medical records do...
- 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...
- 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;
- 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...
- 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...
- 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...
- 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 treatment 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);
- people who anticipate working during the hours of midnight to 6 AM during the study;
- people with narcolepsy;
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Decatur, Georgia, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Rochester, New York, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Decatur, Georgia, United States; Boston, Massachusetts, United States; New York, New York, United States; Rochester, New York, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.