A Study of a Novel EEG Neurofeedback System for PTSD Treatment (NCT06770998)

Usually NOT eligible if any of the following apply:

• Exclusion Criteria 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;
• 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;