Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

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.

Conditions

• Schizophrenia and Predominant Negative Symptoms

Interventions

DEVICE

Neuronavigated 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.

DEVICE

BEAM-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.

DEVICE

Sham 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.

Sponsors & Collaborators

• Centre de recherche CERVO

  collaborator UNKNOWN

• Magnus Medical

  collaborator INDUSTRY

• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

  collaborator OTHER

• Douglas Mental Health University Institute

  lead OTHER

Principal Investigators

• David Benrimoh, MD.CM., MSc., MSc., FRCPC · McGill University, Department of Psychiatry

• Olivier Roy, MD · Centre de recherche CERVO - Université Laval

• Stéphane Potvin, PhD · Institut Universitaire en Santé Mentale de Montréal

• Lena Palaniyappan, MD, PhD · Douglas Mental Health Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2027-12-31

Completion

2028-05-31

Countries

• Canada

Study Locations