Post-Traumatic Stress Disorder in AdolescenceNCT06854328
The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
A study testing Prism in people with Post-Traumatic Stress Disorder in Adolescence, run by GrayMatters Health Ltd. at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Post-Traumatic Stress Disorder in Adolescence
- What is being tested?
- Prism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Jun 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 12 to 21 years.
- Any gender.
- Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- ≥1 year since index trauma.
- 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.
- For candidate participants 18 years old and above: Willingness and ability to provide informed consent for their study participation.
- English speaking, writing and reading.
- Normal or corrected-to-normal vision and hearing.
Who cannot join
- 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.
- Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
- 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.
- Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.
- 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.
- Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.
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- 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.
- 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.
- 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.
- 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).
- Any unstable medical condition, as per the clinical judgement of the investigator.
- Enrollment in another interventional clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
- Female subjects who are pregnant, nursing, or who plan to become pregnant while in the trial.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Terry Leon, 646-754-5043, terry.leon@nyulangone.org
General, Teenptsdtxstudy@NYUlange.org
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 3303403
Sharon Baltansky, B.A., 052-6668419, Innomind.research@sheba.health.gov.il
Maayan Nur, M.S.C, 052-6668419, Maayan.Nur@sheba.health.gov.il
About this study
Official title: 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)
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.
Read the detailed description
This study will be a Prospective, Single Arm, Open Label Trial, aiming to confirm the safety of the Prism system, adjunct to the standard of care, in adolescent subjects with PTSD.
Up to 45 subjects, but not less than 35, will be enrolled, and all will undergo Prism neurofeedback training. Participants will complete 15(±3) neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks. A mid-training assessment will take place after 7 neurofeedback training sessions (week 4) and at the end of the training regimen (after completing the 15 ± 3 neurofeedback training - Week 8-9). A follow-up assessment will occur one (1) month after completing the last Prism training session.
- Being tested
- Prism
- Keywords
- Neurofeedback, PTSD in adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrismDevice
Prism is using an amygdala-fMRI-guided model for processing EEG signals. The model, termed EEG fMRI pattern (EFP), uses several electrodes EEG-signal to produce a real time amygdala-EFP biomarker signal. GrayMatters' product, Prism, is used to train patients in downregulating the amygdala-derived-EFP biomarker during therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 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. Receives: Device: Prism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety reporting
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.
Measured: 1 month
Secondary outcomes (2)
Proportion of participants improved in CAPS-5
Assess the proportion of participants who demonstrate clinically meaningful improvement in the Clinician Administered PTSD Scale (CAPS-5) from Baseline to the post-training assessment visit (week 9)
Measured: 9 weeks
Proportion of participants improved in PCL-5
Assess the proportion of participants who demonstrate clinically meaningful improvement in the PTSD Checklist for DSM-5 (PCL-5) from Baseline to the post training assessment visit (week 9).
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start11 Jun 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GrayMatters Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ADAR SHANI, Study director, GrayMatters Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854328
- Sponsor's protocol ID
- CLP008
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06854328
- Acronym / sponsor ID
- CLP008
- Keywords
- Neurofeedback, PTSD in adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- GrayMatters Health Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a Prospective, Single Arm, Open Label Trial, aiming to confirm the safety of the Prism system, adjunct to the standard of care, in adolescent subjects with PTSD.
Up to 45 subjects, but not less than 35, will be enrolled, and all will undergo Prism neurofeedback training. Participants will complete 15(±3) neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks. A mid-training assessment will take place after 7 neurofeedback training sessions (week 4) and at the end of the training regimen (after completing the 15 ± 3 neurofeedback training - Week 8-9). A follow-up assessment will occur one (1) month after completing the last Prism training session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: PrismEligible 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 may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Ages 12 to 21 years.
- Any gender.
- Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- ≥1 year since index trauma.
- 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.
Key exclusion criteria (13 listed)
- 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.
- Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
- 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.
- Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrismPrism is using an amygdala-fMRI-guided model for processing EEG signals. The model, termed EEG fMRI pattern (EFP), uses several electrodes EEG-signal to produce a real time amygdala-EFP biomarker signal. GrayMatters' product, Prism, is used to train patients in downregulating the amygdala-derived-EFP biomarker during therapy sessions. | Device | Single arm |
Primary outcome
Safety reporting
Time frame: 1 month
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.
2 secondary outcomes
Proportion of participants improved in CAPS-5
Time frame: 9 weeks
Proportion of participants improved in PCL-5
Time frame: 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ADAR SHANI study director
GrayMatters Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism in people with Post-Traumatic Stress Disorder in Adolescence, run by GrayMatters Health Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Yarden (+972-524897823, jennifer@graymatters-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety reporting (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.