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

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 Overview

• Status: Withdrawn
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Device: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CAPS-5 score from screening to completion	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.	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)

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 20-00792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Requests may be directed to Lisa.Voltolina@nyulangone.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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