Post-Traumatic Stress Disorder (PTSD) Clinical Trial
Official title:
THE PRISM-PTSD PILOT TRIAL (Process-Instructed Self Neuro-Modulation ("Prism") Pilot Trial for Post-Traumatic Stress Disorder)
NCT number | NCT04891614 |
Other study ID # | CLP001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 29, 2020 |
Est. completion date | June 1, 2022 |
Verified date | April 2022 |
Source | GrayMatters Health Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 87 |
Est. completion date | June 1, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Rambam Health Care Campus | Haifa | |
Israel | Mental Health Center in Be'er Ya'akov | Ness Ziona | |
Israel | Sheba Medical Center | Ramat Gan | |
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
GrayMatters Health Ltd. |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | Patient satisfaction survey | To quantify patient satisfaction from the EFP-NF training using survey | through study completion, an average of 5 month | |
Other | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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