Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder
Status
Withdrawn
Conditions
Post-traumatic Stress Disorder
Treatments
Device: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)
Details and patient eligibility
About
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.
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
0 participants in 1 patient group
Patients diagnosed with PTSD
Experimental group
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.
Treatment:
Device: PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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