The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
Recruiting
N/A
Interventional Study
Post-Traumatic Stress Disorder in Adolescence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 12 – 21
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- GrayMatters Health Ltd. · Industry
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Ages 12 to 21 years.
2. Any gender.
3. Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
4. ≥1 year since index trauma.
5. For candidate participants under 18 years old: Willingness and ability to pro…
Contacts