Status:
COMPLETED
The PRISM Pilot Trial for Post-Traumatic Stress Disorder
Lead Sponsor:
GrayMatters Health Ltd.
Conditions:
Post-Traumatic Stress Disorder (PTSD)
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief 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-Tr...
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...
Eligibility Criteria
Inclusion
- Ages 22 to 65
- Any gender
- Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- 1 to 20 years since index trauma
- Ability to give signed, informed consent
- Normal or corrected-to-normal vision
- Normal or corrected to normal hearing
- Subject is able to adhere to the study schedule
Exclusion
- 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.
- Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder
- 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
- Lifetime diagnosis of autism, mental retardation at the discretion of the investigator.
- 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
- 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
- Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs)
- 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
- 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
- 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
- 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)
- Any unstable medical condition, as per the clinical judgement of the investigator
- In process of establishing/changing governmental/institutional compensation payments for PTSD symptoms
- Enrollment in another clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Key Trial Info
Start Date :
November 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04891614
Start Date
November 29 2020
End Date
June 1 2022
Last Update
June 1 2022
Active Locations (5)
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1
NYU Langone Health
New York, New York, United States, 10016
2
Barzilai Medical Center
Ashkelon, Israel
3
Rambam Health Care Campus
Haifa, Israel, 3109601
4
Mental Health Center in Be'er Ya'akov
Ness Ziona, Israel, 70350