The PRISM Pilot Trial for Post-Traumatic Stress Disorder

NCT04891614 | Completed FDA Device

• 1 other identifier: CLP001
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 5

Brief Summary

A Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD)

Conditions

Post-Traumatic Stress Disorder (PTSD)

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS - 5)

  The primary objective of this study is to assess the proportion of subjects who demonstrate clinically meaningful improvement in the Clinician Administered PTSD Scale (CAPS - 5) score from Baseline to the 3 months follow-up visit. Clinically meaningful improvement is defined here as a 6-point reduction or more in the CAPS-5 score.

  Baseline visit (Week 1) and 3 month Follow-up visit

Secondary Outcomes (4)

• PCL-5 response rate

  Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit

• ERQ score

  Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit

• PHQ-9 score

  Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit

• Clinical Global Impression (CGI)

  Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit

Other Outcomes (4)

• Abbreviated PCL (APCL)

  through study completion, an average of 8 weeks

• learning success of the EFP-based neurofeedback

  through study completion, an average of 8 weeks

• Patient satisfaction survey

  through study completion, an average of 5 month

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects diagnosed with PTSD will be recruited from the community and from local clinical programs. All subjects will undergo Prism neurofeedback training.

Device: PRISM

Interventions

PRISM DEVICE

Subjects will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks.

Treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 22 to 65
• Any gender
• Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
• to 20 years since index trauma
• Ability to give signed, informed consent
• Normal or corrected-to-normal vision
• Normal or corrected to normal hearing
• Subject is able to adhere to the study schedule

You may not qualify if:

• Have completed two or more full courses of trauma-focused therapy in the past (i.e., EMDR, Prolong Exposure Therapy, etc.), eligibility will be deemed upon the clinical judgment of the investigator.
• Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder
• Lifetime diagnosis of autism, mental retardation at the discretion of the investigator.
• Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit (as defined in DSM-5-substance use disorder) or at screening visit
• Any prescribed Benzodiazepine which cannot be ceased for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or which cannot be replaced with short-acting benzodiazepines that are taken only for sleeping during the night
• Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs)
• Any change in or initiation of- SSRIs or SNRIs antidepressants within the past 4 weeks. At the time of recruitment, subjects must have no intention of changing their medication or psychotherapy during the study duration
• Any suicidal behavior in the past 1 year (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period
• 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
• 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 unstable medical condition, as per the clinical judgement of the investigator
• In process of establishing/changing governmental/institutional compensation payments for PTSD symptoms
• Enrollment in another clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Sponsors & Collaborators

• GrayMatters Health Ltd.: lead

Study Sites (5)

NYU Langone Health

New York, New York, 10016, United States

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Mental Health Center in Be'er Ya'akov

Ness Ziona, 70350, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Adar Shani

  GrayMatters Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-arm, open-label study

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 18, 2021
• Study Start: November 29, 2020
• Primary Completion: May 31, 2022
• Study Completion: June 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4); US (1)