Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Locations
- 1
- Primary Endpoint
- Change in PCL-5 score from baseline to completion
Study Overview
Brief Summary
This is a single-arm, open-label feasibility study. A maximum of 15 participants will be enrolled. All participants will undergo a novel neurofeedback intervention, targeting down-regulation of deep limbic structures, specifically the amygdalae. Participants will complete 12 neurofeedback sessions delivered twice weekly over 6 consecutive weeks. The intervention will be delivered via the PRISM platform.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults ages 18-65 years
- •Able to provide signed informed consent
- •Any gender
- •Diagnosis of PTSD as established by DSM-V
- •1 to 15 years since index trauma
- •Taking a stable dose of SSRI antidepressants for at least 3 months OR un-medicated for at least 2 months
- •Normal or corrected-to-normal vision
- •Normal or corrected-to-normal hearing
- •No intention of changing medication or psychotherapy for the duration of the study at the time of recruitment
Exclusion Criteria
- •Concurrent substance abuse
- •Use of any prescribed benzodiazepine
- •Lifetime bipolar disorder, psychotic disorder, autism, mental retardation. Comorbid mood and anxiety disorders will be permitted if they are not the primary focus of clinical attention
- •Active suicidality within past year, or history of suicide attempt in past 2 years
- •Any history of severe past drug dependence (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
- •Any unstable medical or neurological condition
- •Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury [TBI] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
- •Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs)
- •Any change in accepted psychotropic medication within the past 2 months
- •Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy [CPT], Prolonged Exposure [PE], Eye Movement -Desensitization and Reprocessing [EMDR]); continuation of established maintenance supportive therapy will be permitted
- •Significant hearing loss or severe sensory impairment
- •Enrollment in another research study testing an experimental, clinical, or behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months
Arms & Interventions
Patients diagnosed with PTSD
7-15 men and women with PTSD will be recruited from the community and from local clinical programs through a multi-modal outreach program.
Intervention: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM) (Device)
Outcomes
Primary Outcomes
Change in PCL-5 score from baseline to completion
Time Frame: Baseline visit (Week 1), and Post-Intervention Visit (Week 9)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items.
Change in CAPS-5 score from screening to completion
Time Frame: Screening visit (Week 0), and Post-Intervention Visit (Week 9)
The CAPS-5 is a 30-item structured interview used to: * Make current (past month) diagnosis of PTSD * Make lifetime diagnosis of PTSD * Assess PTSD symptoms over the past week "1, 2" rule is used to determine a diagnosis: a frequency score of 1 (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score 2 (scale 0 = "none" to 4 = "extreme") is required for a particular symptom to meet criterion. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms.
Secondary Outcomes
No secondary outcomes reported