Health TrialsbyHealthPanel

The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents

ConditionPost-Traumatic Stress Disorder in Adolescence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorGrayMatters Health Ltd.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Prism

    Device

    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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month

Secondary outcomes

1

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)

Time frame
9 weeks
2

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).

Time frame
9 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GrayMatters Health Ltd.

Lead sponsor

Source ClinicalTrials.gov
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