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)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Post Traumatic Stress Disorder (ptsd)
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Age: Between 22 - 65 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants will provide written informed consent
- Participants diagnosed with Post Traumatic Stress Disorder (PTSD)
- Those who have 1 to 20 years since index trauma
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
- Able to adhere to the study schedule
You may not be eligible for this study if the following are true:
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- Have completed two or more full courses of trauma-focused therapy in the past
- Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder
- Has any mood disorder and anxiety disorder in the last 6 months
- Lifetime diagnosis of autism, mental retardation
- Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit
- Any prescribed benzodiazepine which cannot be ceased for the duration of the study or which cannot be replaced with short-acting benzodiazepines that are only taken 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
- Any suicidal behavior in the past 1 year
- 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, epilepsy, or other major neurological abnormality, including a history of traumatic brain injury
- Any unstable medical condition
- In the process of establishing /changing governmental/institutional payments for PTSD symptoms
- Enrollment in another clinical study at screening or within two months prior to screening, or intended within the duration of the study
- Women who are pregnant, nursing, or plan to become pregnant while in the trial
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.