Prism for PTSD

Overseen By Jennifer Yarden

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: GrayMatters Health Ltd.

Must not be taking: Psychotropics

Disqualifiers: Schizophrenia, Bipolar, Autism, Substance use, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 8-9 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires that participants do not change or start any new psychotropic medications within the 4 weeks before joining and during the study. If you are on stable medication, you can continue, but you should not plan to change it during the trial.

How does the Prism for PTSD treatment differ from other PTSD treatments?

The Prism for PTSD treatment is unique because it may incorporate innovative approaches like web-based self-help tests to identify individuals at risk and encourage them to seek help, which is not commonly found in traditional PTSD treatments. ^{1 2 3 4 5}

Who Is on the Research Team?

ADAR SHANI

Principal Investigator

GrayMatters Health

Are You a Good Fit for This Trial?

This trial is for adolescents with PTSD. Participants will use a software called Prism, which requires them to have EEG-NF training sessions. The goal is to see if it's safe and helps reduce PTSD symptoms in young people.

Inclusion Criteria

It has been over a year since my traumatic event.

I am under 18 and both I and my guardian agree to my participation.

I can speak, write, and read English.

Exclusion Criteria

Any unstable medical condition, as per the clinical judgement of the investigator

I have been diagnosed with a specific mental health condition.

I have moderate to severe ADHD symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Prism neurofeedback training sessions delivered twice per week over 8 consecutive weeks

8-9 weeks

15 visits (in-person)

Mid-training Assessment

Assessment after 7 neurofeedback training sessions to evaluate progress

Week 4

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prism

Trial Overview Prism, a software used alongside standard PTSD treatments, is being tested on adolescents. It uses EEG signals to potentially aid in managing PTSD symptoms through fifteen training sessions.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

Eligible participants diagnosed with PTSD will be recruited from the community and from local clinical programs. All subjects will undergo Prism neurofeedback training. Participants will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks.

Who Is Running the Clinical Trial?

GrayMatters Health Ltd.

Lead Sponsor

Trials

4

Recruited

460+

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Mobile Insight in Risk, Resilience, and Online Referral (MIRROR): Psychometric Evaluation of an Online Self-Help Test. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Psychological interventions for posttraumatic stress disorder and depression in refugees: A meta-analysis of randomized controlled trials. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Psychotherapy of posttraumatic stress disorders]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Customized computer-based administration of the PCL-5 for the efficient assessment of PTSD: A proof-of-principle study. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Psychotherapeutic Group Intervention for Traumatized Male Refugees Using Imaginative Stabilization Techniques-A Pilot Study in a German Reception Center. [2020]