Accelerated brain stimulation to reduce negative symptoms of schizophrenia
Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
This will test whether a fast course of noninvasive brain stimulation given over five days can help people with schizophrenia who have marked negative symptoms like low motivation and reduced emotional expression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Douglas Mental Health University Institute Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Trial ID | NCT07428460 on ClinicalTrials.gov |
What this trial studies
This randomized, sham-controlled pilot uses an accelerated intermittent theta-burst stimulation (iTBS) protocol delivered over five consecutive days to target negative symptoms in people with schizophrenia spectrum disorders. Participants are randomized to active or sham stimulation and to one of two targeting methods for placing the stimulation, with treatment guided by neuronavigation or a scalp-based approach. All participants complete baseline clinical interviews, questionnaires, and a brain scan, then receive the condensed treatment course and return for post-treatment outcome assessments. Primary outcomes focus on changes in negative symptom severity, while secondary outcomes include depressive symptoms, functional measures, and safety/tolerability.
Who should consider this trial
Good fit: Adults with a confirmed schizophrenia-spectrum diagnosis, clinically significant and stable negative symptoms, at least six months of illness duration, stable medications for four weeks, capacity to consent, and eligibility for MRI and TMS are ideal candidates.
Not a fit: People with contraindications to TMS or MRI, a recent history of ECT or prior rTMS, active uncontrolled substance use (other than cannabis), pregnancy, or predominant positive symptoms are less likely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could reduce negative symptoms such as low motivation and social withdrawal and improve day-to-day functioning with a short, more accessible treatment schedule.
How similar studies have performed: Prior rTMS studies targeting the left dorsolateral prefrontal cortex have shown some benefit for negative symptoms, but accelerated multi-session-per-day iTBS protocols are newer and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder * Duration of illness ≥ 6 months * Clinically significant negative symptoms * Must have been on a stable pharmacological treatment for at least 4 weeks before entering the study * Clinicians will confirm that patients' negative and positive symptoms have been stable per their clinical opinion for at least 3 months. * Participants must be able to provide informed consent * Ability to undergo MRI scanning Exclusion Criteria: * Pregnancy, lactation, or an intrauterine device * History of electroconvulsive therapy (ECT) in the past 6 months * Use of licit or illicit substances (excluding cannabis) during the week of treatment and in the 24 hours prior to fMRI scans * Contraindications for TMS * Previous treatment with rTMS * Documented history of significant intellectual disability * Primary diagnosis of psychotic disorder secondary to a medical condition or substance-induced psychosis.
Where this trial is running
Montreal, Quebec and 2 other locations
- Institut Universitaire en Santé Mentale de Montréal — Montreal, Quebec, Canada (Not_yet_recruiting)
- Institut universitaire de santé mentale de Québec - Centre de recherche CERVO — Québec, Quebec, Canada (Not_yet_recruiting)
- McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC — Verdun, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: David Benrimoh, MD.CM., MSc., MSc., FRCPC — McGill University, Department of Psychiatry
- Study coordinator: Ashley S. Choucroun
- Email: ashley.choucroun.comtl@ssss.gouv.qc.ca
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.