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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04496557
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder	Device: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single-arm, open-label feasibility studysingle-arm, open-label feasibility study
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Apr 1, 2021
• Actual Study Completion Date: Apr 1, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Device: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM); Neurofeedback sessions targeting down-regulation of deep limbic structures, specifically the amygdala, delievered via PRISM: a non-significant risk device (software) intended to be used in research studies testing the clinical efficacy of an innovative paradigm for EEG-based neurofeedback. The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on non-consecutive days. Each session will last 30 minutes. EFP-EEG-NF training: Each NF training session consists of 5 consecutive sequences of NF presentations. During a "watch" condition (60 seconds) participants are instructed to passively view the animation, and are told that that the scenario does not influence their brain activity. In the "regulate" phase (60 seconds) participants are instructed to lower the room's unrest level. A "rest" phase (15 seconds) follows each sequence, allowing participants to relax.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Charles Marmar, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04496557
• Other Study ID Numbers: 20-00792
• First Posted: Aug 3, 2020
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jun 14, 2021