The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents (NCT06854328) | Clinical Trial Compass
RecruitingNot Applicable
The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
United States, Israel45 participantsStarted 2025-06-11
Plain-language summary
Prism is a software as a medical device (SaMD) to be prescribed by clinicians as an adjunct to the standard of care treatment of patients with PTSD. The Prism software device runs on a laptop using an EEG signal input (g).Nautilos PRO (K171669).
The primary objective of the study is to extend the use of the FDA cleared Prism for PTSD (K222101) to an adolescent population and to confirm the safety of fifteen (15±3) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms in adolescents. The study aims to demonstrate the safety profile of Prism, having no device-related serious adverse events (SAEs), consistent with findings in the adult population, throughout the course of Prism treatment in an adolescent population.
Who can participate
Age range12 Years – 21 Years
SexALL
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Inclusion criteria
✓. Ages 12 to 21 years.
✓. Any gender.
✓. Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
✓. ≥1 year since index trauma.
✓. For candidate participants under 18 years old: Willingness and ability to provide assent, with the participant's legal guardian able and willing to provide informed consent for their study participation.
✓. For candidate participants 18 years old and above: Willingness and ability to provide informed consent for their study participation.
✓. English speaking, writing and reading.
✓. Normal or corrected-to-normal vision and hearing.
Exclusion criteria
✕. Have completed one or more full courses of trauma-focused therapy in the past (i.e., Eye Movement Desensitization and Reprocessing \[EMDR\], Prolong Exposure Therapy etc.), eligibility will be deemed upon the clinical judgement of the investigator.
✕. Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
✕. Any mood or anxiety disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), that has been the primary focus of mental health treatment within the 6 months prior to screening, based on the clinical judgment of the site investigator.
✕. Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.
✕. Diagnosis of moderate or severe substance use disorder within the last 3 months of the screening visit (as defined in DSM-5-substance use disorder) or at the screening visit.
✕. Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.
✕. Any change in- or initiation of- psychotropic medications 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 within 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.