Status:
WITHDRAWN
Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder
Lead Sponsor:
NYU Langone Health
Conditions:
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04496557
Start Date
October 1 2020
End Date
April 1 2021
Last Update
June 14 2021
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016