Accelerated Brain Stimulation for Young People at Risk of Psychosis
Official title: Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis
Run by Douglas Mental Health University Institute · NCT07786714 · Data updated 2026-11-12
This study tests a five-day accelerated brain-stimulation treatment to see if it is safe and tolerable for young people at risk for psychosis and to explore biomarkers that might show whether it works.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 34 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Douglas Mental Health University Institute Academic / other |
| Locations | 1 site (Verdun, Quebec) |
| Status | Recruiting |
| Started | August 2026 |
| Main results expected | August 2028 |
| Study ends | December 2029 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT07786714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-34 who meet CHR-P criteria (SIPS-confirmed) and have stable enough condition to participate.
✕Probably not a fit
Individuals with contraindications to TMS, recent substance use during treatment, or prior rTMS exposure may be less likely to benefit or participate safely.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this pilot, 40 participants aged 18-34 at clinical high risk for psychosis are randomized to active accelerated intermittent theta burst stimulation or sham stimulation targeting the left dorsolateral prefrontal cortex. The treatment is delivered over five consecutive days using a BEAM-F3 scalp target, without MRI navigation. Researchers will monitor safety, tolerability, depressive symptoms, cognitive performance, and digital biomarkers from wearables, smartphones, and speech analysis to identify potential treatment-related signals for future trials.
Why it matters
Potential benefit: If successful, the approach could offer a low-burden intervention that may help reduce symptoms and improve early indicators of risk in CHR-P individuals.
How similar studies have gone: Prior rTMS approaches for depression and certain psychotic symptoms support the rationale, but accelerated iTBS in CHR-P is exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meets clinical CHR-P criteria, confirmed by the Structured Interview for Psychosis-Risk Syndromes (SIPS) * Clinical team confirms sufficient stability to participate * Able to provide informed consent Exclusion Criteria: * Pregnancy, lactation, or intrauterine device * History of electroconvulsive therapy (ECT) in the past 6 months * Substance use during the treatment week (cigarettes and cannabis excluded from this consideration) * Contraindications for TMS (e.g., metal implants in head/neck, seizure history, brain tumor/neurosurgery, severe cardiac disease) * Previous rTMS treatment * Documented history of significant intellectual disability
Where it's running
-
McGill Lab for Computational Psychiatry and Translation
Verdun, Quebec, Canada Recruiting
Study contacts
- Principal investigator: David Benrimoh — McGill University, Department of Psychiatry
- Study coordinator: Ashley Choucroun
- Email: ashley.choucroun.comtl@ssss.gouv.qc.ca
- Phone: 5146593488
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.