The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorGrayMatters Health Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Prism
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov