Prism neurofeedback for PTSD in adolescents and young adults

A Prospective, Single Arm, Open Label Trial, to Confirm Safety and Effectiveness of Prism, as an Adjunct to Standard of Care, in Adolescents With Post-Traumatic Stress Disorder (PTSD)

This trial will test whether the Prism neurofeedback software, used alongside usual care, is safe and may reduce PTSD symptoms in people aged 12–21.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 12 Years to 21 Years
• Sex: All
• Sponsor: GrayMatters Health Ltd. (Industry-sponsored)
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT06854328 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, open-label trial that will enroll 35–45 adolescents and young adults with DSM-5 PTSD to receive Prism neurofeedback as an adjunct to standard care. Participants will complete 15 (±3) EEG-guided neurofeedback sessions delivered twice weekly over about eight weeks, with a mid-training visit after seven sessions, an end-of-training visit, and a one-month follow-up. The Prism software runs on a laptop using EEG input and the primary objective is to confirm the safety profile in this adolescent population, specifically the absence of device-related serious adverse events. All participants will receive the same active intervention without a control group, and outcomes will focus on safety and symptom changes over the training and follow-up period.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adolescents and young adults aged 12–21 with DSM-5 PTSD at least one year after the index trauma, normal or corrected vision/hearing, and the ability to provide consent or assent with guardian consent as required.

Not a fit: Patients with psychotic disorders, those who recently completed full courses of trauma-focused therapy (per investigator judgment), or those unable to attend in-person sessions or comply with procedures are less likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, Prism could provide a noninvasive adjunct therapy that helps reduce PTSD symptoms in adolescents while showing a favorable safety profile.

How similar studies have performed: Prism has prior FDA clearance for adult PTSD and adult studies have supported its safety and symptom effects, but its use in adolescents has not been confirmed.

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 provide assent, with the participant's legal guardian able and willing to provide informed consent for their study participation.
6. For candidate participants 18 years old and above: Willingness and ability to provide informed consent for their study participation.
7. English speaking, writing and reading.
8. Normal or corrected-to-normal vision and hearing.

Exclusion Criteria:

1. 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.
2. Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
3. 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.
4. Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.
5. Diagnosis of moderate or severe substance use disorder within the last 3 months of the screening visit (as defined in DSM-5-substance use disorder) or at the screening visit.
6. Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.
7. Any change in- or initiation of- psychotropic medications within the past 4 weeks. At the time of recruitment, subjects must have no intention of changing their medication or psychotherapy during the study duration.
8. Any suicidal behavior within the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior), prior to screening and during the screening period.
9. Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy \[CPT\], Prolonged Exposure \[PE\], Eye Movement Desensitization and Reprocessing \[EMDR\]). However, continuation of established maintenance supportive therapy will be permitted.
10. Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury \[TBI\] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days).
11. Any unstable medical condition, as per the clinical judgement of the investigator.
12. Enrollment in another interventional clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
13. Female subjects who are pregnant, nursing, or who plan to become pregnant while in the trial.

Where this trial is running

New York, New York and 1 other locations

• NYU Langone Health — New York, New York, United States (Recruiting)
• Sheba Medical Center — Ramat Gan, Israel (Recruiting)

Study contacts

• Study coordinator: Jennifer Yarden

Conditions Post-Traumatic Stress Disorder in Adolescence; Neurofeedback; PTSD in adolescent