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The PRISM Pilot Trial for Post-Traumatic Stress Disorder

NCT04891614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2022-06-01

No results posted yet for this 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)

Conditions

  • Post-Traumatic Stress Disorder (PTSD)

Interventions

DEVICE

PRISM

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

Sponsors & Collaborators

  • GrayMatters Health Ltd.

    lead INDUSTRY

Principal Investigators

  • Adar Shani · GrayMatters Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-29
Primary Completion
2022-05-31
Completion
2022-06-01
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891614 on ClinicalTrials.gov