RecruitingNot ApplicableNCT07428460

Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia


Sponsor

Douglas Mental Health University Institute

Enrollment

75 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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. We 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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a form of accelerated brain stimulation therapy called accelerated TMS (transcranial magnetic stimulation) for the negative symptoms of schizophrenia — such as social withdrawal, lack of motivation, and flat emotional expression — which are often difficult to treat with medication alone. **You may be eligible if...** - You have a confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder - Your illness has lasted at least 6 months - You have significant negative symptoms - Your medication and symptoms have been stable for at least 3–4 months - You are able to provide informed consent and undergo MRI scanning **You may NOT be eligible if...** - You are pregnant, breastfeeding, or have an IUD - You have had electroconvulsive therapy (ECT) within the past 6 months - You have used illicit substances (excluding cannabis) within the week before treatment - You have a contraindication to MRI or TMS (such as metal in the head) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeuronavigated Intermittent Theta Burst Stimulation

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.

DEVICEBEAM-F3 Intermittent theta burst stimulation

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.

DEVICESham Intermittent Theta Burst Stimulation

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.


Locations(3)

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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NCT07428460