Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder (PRISM)
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|ClinicalTrials.gov Identifier: NCT04496557|
Recruitment Status : Withdrawn (The investigators received funding for a near-identical FDA regulated trial before opening this study to enrollment - the IRB requested closure of the unfunded pilot trial to create a new submission.)
First Posted : August 3, 2020
Last Update Posted : June 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Stress Disorder||Device: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single-arm, open-label feasibility study|
|Masking:||None (Open Label)|
|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 :||October 1, 2020|
|Actual Primary Completion Date :||April 1, 2021|
|Actual Study Completion Date :||April 1, 2021|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496557
|United States, New York|
|NYU Langone Health|
|New York, New York, United States, 10016|
|Principal Investigator:||Charles Marmar, MD||NYU Langone Health|