The PRISM Pilot Trial for Post-Traumatic Stress Disorder

Completed · Not applicable

Conditions studied: Post-Traumatic Stress Disorder (PTSD)

In brief

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)

Key facts

Study ID

NCT04891614

Run by

GrayMatters Health Ltd.

People needed

87

Starts

2020-11-29

Expected to finish

2022-06-01

Last updated by the study team

2022-06-01

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Langone Health — New York, New York, United States
• 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, Israel

Full record on ClinicalTrials.gov

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