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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with PTSD | Experimental | 7-15 men and women with PTSD will be recruited from the community and from local clinical programs through a multi-modal outreach program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CAPS-5 score from screening to completion | The CAPS-5 is a 30-item structured interview used to:
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. | Screening visit (Week 0), and Post-Intervention Visit (Week 9) |
| Change in PCL-5 score from baseline to completion | 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. | Baseline visit (Week 1), and Post-Intervention Visit (Week 9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Marmar, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Lisa.Voltolina@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health.
Requests may be directed to Lisa.Voltolina@nyulangone.org
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single-arm, open-label feasibility study
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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