Clinical trial NCT04891614: The PRISM Pilot Trial for Post-Traumatic Stress Disorder
Official title: THE PRISM-PTSD PILOT TRIAL (Process-Instructed Self Neuro-Modulation ("Prism") Pilot Trial for Post-Traumatic Stress Disorder)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder (PTSD)
Keywords: PTSD
Lead sponsor: GrayMatters Health Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 87
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm, open-label study
Primary purpose: TREATMENT

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-Traumatic Stress Disorder (PTSD)

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS - 5)
timeFrame: Baseline visit (Week 1) and 3 month Follow-up visit
Secondary outcomes:
measure: PCL-5 response rate
timeFrame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
measure: ERQ score
timeFrame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
measure: PHQ-9 score
timeFrame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
measure: Clinical Global Impression (CGI)
timeFrame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Other outcomes:
measure: Abbreviated PCL (APCL)
timeFrame: through study completion, an average of 8 weeks
measure: learning success of the EFP-based neurofeedback
timeFrame: through study completion, an average of 8 weeks
measure: Patient satisfaction survey
timeFrame: through study completion, an average of 5 month
measure: Remission rate
timeFrame: Baseline visit (Week 1), Post-Intervention Visit (Week 9) and 3 month Follow-up visit
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Ness Ziona
country: Israel
facility: Mental Health Center in Be'er Ya'akov
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: GrayMatters Health
name: Adar Shani
role: STUDY_DIRECTOR
References: