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CompletedNCT04891614Updated Jun 1, 2022

The PRISM Pilot Trial for Post-Traumatic Stress Disorder

An interventional study of PRISM in Post-Traumatic Stress Disorder (PTSD), sponsored by GrayMatters Health Ltd.. Completed at 5 sites in 2 countries. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by GrayMatters Health Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2022, 4 years 4 months ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled Nov 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Not applicable
Ages
22 Years to 65 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Post-Traumatic Stress Disorder (PTSD)

Keywords

  • PTSD
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 87 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

GrayMatters Health Ltd. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
87 participants (actual)

Study arms

  • 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

Interventions

  • DevicePRISM

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

06

What researchers measure

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.

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

Secondary outcomes

  1. 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

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

  2. ERQ score

    Change from baseline to Month 3 visit in ERQ score

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

  3. PHQ-9 score

    Change from baseline to Month 3 visit in PHQ-9 score

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

  4. Clinical Global Impression (CGI)

    Change from baseline to Month 3 visit in CGI score

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

Other outcomes

  1. Abbreviated PCL (APCL)

    To assess the change in the score of the abbreviated PCL scale (APCL, assessed weekly during the EFP-NF training period)

    Time frame: through study completion, an average of 8 weeks

  2. 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)

    Time frame: through study completion, an average of 8 weeks

  3. Patient satisfaction survey

    To quantify patient satisfaction from the EFP-NF training using survey

    Time frame: through study completion, an average of 5 month

  4. Remission rate

    To assess the Remission rate at post training visit (8-9 weeks) and at the 3 months follow-up visit

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

07

Study locations

5 sites
  • NYU Langone Health
    New York, New York 10016, United States
  • Barzilai Medical Center
    Ashkelon, Israel
  • Rambam Health Care Campus
    Haifa, 3109601, Israel
  • Mental Health Center in Be'er Ya'akov
    Ness Ziona, 70350, Israel
  • Sheba Medical Center
    Ramat Gan, 52621, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04891614
Lead sponsor
GrayMatters Health Ltd.
Responsible party
Sponsor
First posted
May 18, 2021
Start date
Nov 29, 2020
Primary completion
May 31, 2022
Completion
Jun 1, 2022
Last update
Jun 1, 2022

Study contacts

Adar Shani
study director · GrayMatters Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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