Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

NCT07428460 | Recruiting

• 3 other identifiers: MP-18-2025-12068401470ASMQCIHR-8401550
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Negative symptoms; Neuromodulation therapy; Non-invasive brain stimulation; Accelerated treatment; Schizophrenia spectrum disorders; TMS; Transcranial Magnetic Stimulation; Outpatient treatment

Outcome Measures

Primary Outcomes (4)

• Change in Avolition/Apathy Subscale Score

  Change in score on the Avolition/Apathy subscale of the Scale for the Assessment of Negative Symptoms (SANS). The SANS Avolition/Apathy subscale ranges from 0 to 25, with higher scores indicating greater negative symptom severity.

  Baseline to 1 week, 1 month, and 3 months post-treatment

• Change in Scale for the Assessment of Negative Symptoms Total Score

  Change in total score on the Scale for the Assessment of Negative Symptoms (SANS). Total scores range from 0 to 125, with higher scores indicating greater negative symptom severity.

  Baseline to 1 week, 1 month, and 3 months post-treatment

• Change in Brief Negative Symptom Scale Total Score

  Change in total score on the Brief Negative Symptom Scale (BNSS). Total scores range from 0 to 78, with higher scores indicating greater negative symptom severity.

  Baseline to 1 week, 1 month, and 3 months post-treatment

• Effect of Targeting Method on Negative Symptoms

  Difference in change in negative symptom severity between targeting methods, as measured by negative symptom outcomes.

  Baseline to 1 week, 1 month, and 3 months post-treatment

Secondary Outcomes (6)

• Change in Affective Processing

  Baseline to 1 week, 1 month, and 3 months post-treatment

• Change in Social Appraisal

  Baseline to 1 week, 1 month, and 3 months post-treatment

• Change in Cognitive Performance

  Baseline to 1 week, 1 month, and 3 months post-treatment

• Change in Montgomery-Åsberg Depression Rating Scale Score

  Baseline to 1 week, 1 month, and 3 months post-treatment

• Change in Calgary Depression Scale for Schizophrenia Score

  Baseline to 1 week, 1 month, and 3 months post-treatment

Study Arms (3)

Active iTBS (Neuronavigated Targeting)

EXPERIMENTAL

Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using neuronavigation-guided targeting.

Device: Neuronavigated Intermittent Theta Burst Stimulation

Active iTBS (BEAM-F3 Targeting)

EXPERIMENTAL

Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using BEAM-F3 targeting.

Device: BEAM-F3 Intermittent theta burst stimulation

Sham iTBS

SHAM COMPARATOR

Participants receive sham iTBS over five consecutive days (ten sessions/day) using the same session structure and procedures as active treatment.

Device: Sham Intermittent Theta Burst Stimulation

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.

Active iTBS (Neuronavigated Targeting)

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.

Active iTBS (BEAM-F3 Targeting)

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.

Sham iTBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead
• Centre de recherche CERVO: collaborator
• Magnus Medical: collaborator
• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal: collaborator

Study Sites (3)

Institut Universitaire en Santé Mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

NOT YET RECRUITING

Institut universitaire de santé mentale de Québec - Centre de recherche CERVO

Québec, Quebec, G1J 2G3, Canada

NOT YET RECRUITING

McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC

Verdun, Quebec, H4H 1R3, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• David Benrimoh, MD.CM., MSc., MSc., FRCPC

  McGill University, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Olivier Roy, MD

  Centre de recherche CERVO - Université Laval

  PRINCIPAL INVESTIGATOR

• Stéphane Potvin, PhD

  Institut Universitaire en Santé Mentale de Montréal

  PRINCIPAL INVESTIGATOR

• Lena Palaniyappan, MD, PhD

  Douglas Mental Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley S. Choucroun

CONTACT

ashley.choucroun.comtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, outcome assessors and treaters are blinded to treatment assignment. Care providers are blinded where feasible based on study procedures. Measures are in place to preserve blinding throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NeuroPsychiatrist

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

CA (3)