Back to resultsFeasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder (PRISM)
Primary Purpose
Post-traumatic Stress Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)
Sponsored by
About this trial
This is an interventional other trial for Post-traumatic Stress Disorder
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients diagnosed with PTSD
Arm Description
7-15 men and women with PTSD will be recruited from the community and from local clinical programs through a multi-modal outreach program.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04496557
Brief Title
Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder
Acronym
PRISM
Official Title
Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
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.
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-arm, open-label feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients diagnosed with PTSD
Arm Type
Experimental
Arm Description
7-15 men and women with PTSD will be recruited from the community and from local clinical programs through a multi-modal outreach program.
Intervention Type
Device
Intervention Name(s)
PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in CAPS-5 score from screening to completion
Description
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.
Time Frame
Screening visit (Week 0), and Post-Intervention Visit (Week 9)
Title
Change in PCL-5 score from baseline to completion
Description
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.
Time Frame
Baseline visit (Week 1), and Post-Intervention Visit (Week 9)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Marmar, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder
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