Can a headset help teens overcome PTSD?
NCT ID NCT06854328
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called Prism, which uses EEG to measure brain activity and trains users to calm a part of the brain linked to stress. Researchers want to see if it is safe and helpful for 45 adolescents aged 12-21 with PTSD, when used alongside their usual therapy. The main goal is to confirm safety, with a secondary focus on symptom improvement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prism device (EEG-based neurofeedback training)
- What this could lead to
- If successful, this could provide a safe, non-drug tool to help adolescents with PTSD better manage their symptoms alongside standard therapy.
- What could go wrong
- This is a small, early-stage trial with no control group, so results may not be conclusive. The device is already cleared for adults, but its effectiveness in teens is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
Contact Email: •••••@•••••
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Sheba Medical Center
RECRUITINGRamat Gan, 3303403, Israel
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