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?

This trial explores a software tool called Prism, designed to reduce PTSD symptoms in young people. Prism uses neurofeedback (brainwave monitoring) during training sessions to support standard PTSD treatments. The goal is to confirm Prism's safety and effectiveness for adolescents, as it has been shown for adults. Individuals who have experienced PTSD for over a year, have not completed trauma-focused therapy, and are willing to attend regular sessions might be suitable candidates. As an unphased trial, participants contribute to innovative research that may enhance PTSD treatment options for young people.

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.

What prior data suggests that the Prism software device is safe for adolescents with PTSD?

Research has shown that the Prism software is safe to use. Previous studies found that using Prism for EEG neurofeedback training did not cause any serious device-related problems. In adults with PTSD (post-traumatic stress disorder), participants completed 15 training sessions without major safety issues.

The FDA has already approved the Prism software for use in adults, indicating it meets strict safety standards. This trial aims to confirm its safety for teens with PTSD. So far, evidence suggests that Prism is well-tolerated, with no serious device-related problems reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Prism is unique because it uses neurofeedback training to help people with PTSD. Unlike traditional treatments like medication and talk therapy, which focus on managing symptoms, Prism aims to retrain the brain's activity patterns. Researchers are excited about this approach because it offers a non-invasive way to address PTSD by potentially altering the brain's response to stress, providing a new avenue for treatment that could complement existing therapies.

What evidence suggests that the Prism software device is effective for treating PTSD in adolescents?

Research has shown that Prism neurofeedback training can help reduce PTSD symptoms. In one study, participants experienced a symptom reduction ranging from 7% to 72%, with an average decrease of 42.5%. This indicates that the Prism system can significantly aid many individuals with PTSD. Previous studies have also found Prism to be safe and effective for adults. In this trial, all participants will undergo Prism neurofeedback training to test these results in teenagers, focusing on safety and symptom reduction. ^{1 2 4 5 6}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT04891614

The PRISM Pilot Trial for Post-Traumatic Stress Disorder The study's primary objective is to assess the safety and effectiveness of fifteen (15) EEG-NF training sessions using the Prism software in reducing PTSD- ...

2. psychiatrictimes.com psychiatrictimes.com/view/study-highlights-efficacy-of-prism-for-ptsd-in-alleviating-chronic-ptsd-symptoms

Study Highlights Efficacy of Prism for PTSD in Alleviating ... A study explored the efficacy of the neurofeedback therapy, Prism for PTSD, in the treatment of posttraumatic stress disorder (PTSD).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06770998

A Study of a Novel EEG Neurofeedback System for PTSD ... The goal of this clinical trial is to learn if training with the Prism system can reduce PTSD symptoms in US military Veterans and civilians with PTSD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10515677/

Neurofeedback for post-traumatic stress disorder: systematic ... The NFB groups showed a reduction in PTSD symptoms post-treatment of between 7% and 72% (median 42.5%), compared with changes in the control groups ranging from ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123006613

Amygdala-derived-EEG-fMRI-pattern neurofeedback for ... The effect of NF training on the PTSD patient's response to non-traumatic stimuli can be measured used validated PTSD instruments. •. Changes from baseline in ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K222101.pdf

March 17, 2023 GrayMatters Health Ltd. Allison Komiyama ... The purpose of the study was to assess the safety and effectiveness of fifteen (15) EEG-Neurofeedback training sessions using the Prism software.