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
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)
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.
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 →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.
Exclusion Criteria:
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.
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
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
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
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
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
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
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
Patient satisfaction survey
To quantify patient satisfaction from the EFP-NF training using survey
Time frame: 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
Time frame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Plan to share: No
No publications or documents are linked to this record.
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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GrayMatters Health Ltd.