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Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

Sponsor: Douglas Mental Health University Institute • ClinicalTrials.gov ID: NCT07428460

Registry updated: 2026-08-20
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Description

The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time. Participants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation. The investigators want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes Participants will be asked to complete clinical interviews and questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment This study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.

Interventions

  • Neuronavigated Intermittent Theta Burst Stimulation (Device)
    Neuronavigated intermittent theta burst stimulation (iTBS) is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil targeting the left dorsolateral prefrontal cortex. Individualized stimulation targets are identified using functional MRI data and are imported into a neuronavigation system to guide coil positioning and orientation throughout treatment. Treatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Each iTBS session is delivered at an intensity corresponding to 110% of the participant's resting motor threshold, with stimulation intensity adjusted for individual cortical depth.
  • BEAM-F3 Intermittent theta burst stimulation (Device)
    BEAM-F3 intermittent theta burst stimulation (iTBS) is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil targeting the left dorsolateral prefrontal cortex. Stimulation targets are identified according to the BEAM-F3 procedure. Treatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Each iTBS session is delivered at an intensity corresponding to 110% of the participant's resting motor threshold, with stimulation intensity adjusted for individual cortical depth.
  • Sham Intermittent Theta Burst Stimulation (Device)
    Sham intermittent theta burst stimulation is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil positioned over the left dorsolateral prefrontal cortex. Coil placement, session structure, and treatment schedule are identical to those used for active stimulation. Treatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Sham stimulation is administered using procedures designed to mimic the experience of active iTBS without producing therapeutic cortical stimulation.

Eligibility 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.

Conditions

Schizophrenia and Predominant Negative Symptoms

Locations

  • Institut Universitaire en Santé Mentale de Montréal — Montreal, Quebec, Canada
  • Institut universitaire de santé mentale de Québec - Centre de recherche CERVO — Québec, Quebec, Canada
  • McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC — Verdun, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record