The PRISM Pilot Trial for Post-Traumatic Stress Disorder

THE PRISM-PTSD PILOT TRIAL (Process-Instructed Self Neuro-Modulation ("Prism") Pilot Trial for Post-Traumatic Stress Disorder)

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)

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Device: PRISM

Detailed Description

Prism is a software device intended for neurofeedback (NF) training (i.e. operant condition based on EEG signals, also known as EEG-biofeedback), to be used in combination with a standard computer and supported EEG hardware. For purposes of this training, information for feedback is derived and processed from several EEG channels. Prism provides visual and/or auditory signals that correspond to the patient's computed EEG signal, which serves as a surrogate indicator of achieving a state of reduced amygdala activity.

The study is 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).

The study population will include subjects diagnosed with Post-Traumatic Stress Disorder (PTSD) from 1 year to 20 years after index trauma. The total expected enrollment is up to 100 subjects in one or more sites.

The study's primary objective is to assess the safety and effectiveness of fifteen (15) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel
    • Barzilai Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Ness Ziona, Israel, 70350
    • Mental Health Center in Be'er Ya'akov
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages 22 to 65
2. Any gender
3. Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
4. 1 to 20 years since index trauma
5. Ability to give signed, informed consent
6. Normal or corrected-to-normal vision
7. Normal or corrected to normal hearing
8. Subject is able to adhere to the study schedule

Exclusion Criteria:

1. 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.
2. Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder
3. Any mood disorder and anxiety disorder according to DSM-5 (in addition to those described in Exclusion 2) that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgment of the investigator
4. Lifetime diagnosis of autism, mental retardation at the discretion of the investigator.
5. 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
6. 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
7. Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs)
8. 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
9. 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
10. 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
11. 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)
12. Any unstable medical condition, as per the clinical judgement of the investigator
13. In process of establishing/changing governmental/institutional compensation payments for PTSD symptoms
14. Enrollment in another clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study
15. Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects diagnosed with PTSD will be recruited from the community and from local clinical programs. All subjects will undergo Prism neurofeedback training.	Device: PRISM; Subjects will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCL-5 response rate	To assess the proportion of subjects who demonstrate clinically meaningful improvement in the PTSD Checklist for DSM-5 (PCL-5). Clinically meaningful improvement is defined here as a 10-point reduction or more in the PCL-5 score	Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
ERQ score	Change from baseline to Month 3 visit in ERQ score	Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
PHQ-9 score	Change from baseline to Month 3 visit in PHQ-9 score	Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Clinical Global Impression (CGI)	Change from baseline to Month 3 visit in CGI score	Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abbreviated PCL (APCL)	To assess the change in the score of the abbreviated PCL scale (APCL, assessed weekly during the EFP-NF training period)	through study completion, an average of 8 weeks
learning success of the EFP-based neurofeedback	To quantify the learning success of the EFP-based neurofeedback (namely: learning volitional down-regulation of the Amyg-EFP signal, over time, during the EFP-NF training period)	through study completion, an average of 8 weeks
Patient satisfaction survey	To quantify patient satisfaction from the EFP-NF training using survey	through study completion, an average of 5 month
Remission rate	To assess the Remission rate at post training visit (8-9 weeks) and at the 3 months follow-up visit	Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit

Collaborators and Investigators

• Sponsor: GrayMatters Health Ltd.
• Investigators: Study Director: ADAR SHANI, GrayMatters Health

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CLP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: No