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NCT06854328 · ClinicalTrials.gov registry record · NA
The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
A NA study of Post-Traumatic Stress Disorder in Adolescence, sponsored by GrayMatters Health.
- Recruiting
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06854328: Recruiting NA study of Post-Traumatic Stress Disorder in Adolescence, sponsored by GrayMatters Health.
NCT06854328 is a NA study of Post-Traumatic Stress Disorder in Adolescence that is actively recruiting participants, run by GrayMatters Health. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06854328, a NA study of Post-Traumatic Stress Disorder in Adolescence, is actively recruiting participants, sponsored by GrayMatters Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 Prism, by closely following and analyzing device-related serious adverse events. The success criterion is defined by no serious adverse event which is deemed as device-related during the study and one month after treatment ends.
Conditions Studied
Interventions
- DEVICE Prism
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-06-11 |
| Est. Completion | 2026-11-01 |
| Phase | NA |
What NCT06854328 shows while recruiting
NCT06854328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Post-Traumatic Stress Disorder in Adolescence appearing as the primary indexed condition, and to 1 intervention - of which Prism is the first listed.
NCT06854328 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06854328 about?
NCT06854328 is a clinical study titled "The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents". 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 u...
What is the current status of trial NCT06854328?
This trial is currently recruiting. It is a NA study. The enrollment target is 45 participants. The study started on 2025-06-11. Estimated completion is 2026-11-01.
What conditions does trial NCT06854328 study?
This clinical trial studies the following conditions: Post-Traumatic Stress Disorder in Adolescence.
What interventions are being tested in trial NCT06854328?
The interventions under investigation include: Prism (DEVICE).
Who is sponsoring clinical trial NCT06854328?
This trial is sponsored by GrayMatters Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06854328 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post-Traumatic Stress Disorder in Adolescence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06854328's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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