Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder

Not Applicable

Withdrawn

• Conditions: Post-traumatic Stress Disorder
• Interventions: Device: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)

• Registration Number: NCT04496557
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Study Start: 2020-10-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with PTSD	PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)	7-15 men and women with PTSD will be recruited from the community and from local clinical programs through a multi-modal outreach program.

Primary Outcome Measures

Name	Time	Method
Change in PCL-5 score from baseline to completion	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	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States