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

NCT ID: NCT04496557

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-04-01

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.

Conditions

Post-traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Marmar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

20-00792

Identifier Type: -

Identifier Source: org_study_id