Recruiting

Neuromodulation Therapy

Sponsor:

Douglas Mental Health University Institute

Code:

NCT07428460

Conditions

Schizophrenia and Predominant Negative Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Neuronavigated Intermittent Theta Burst Stimulation

BEAM-F3 Intermittent theta burst stimulation

Sham Intermittent Theta Burst Stimulation

Study Details

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.

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.

Conditions

Schizophrenia and Predominant Negative Symptoms

Study ID

NCT07428460

Start date

Feb 1, 2026

Status verified date

Aug, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active iTBS (Neuronavigated Targeting)

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

experimental: Active iTBS (BEAM-F3 Targeting)

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

sham comparator: Sham iTBS

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

Interventions

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.

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.

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.

Primary outcome measure

  • Change in Avolition/Apathy Subscale Score [ Time Frame: Baseline to 1 week, 1 month, and 3 months post-treatment ]
  • Change in Scale for the Assessment of Negative Symptoms Total Score [ Time Frame: Baseline to 1 week, 1 month, and 3 months post-treatment ]
  • Change in Brief Negative Symptom Scale Total Score [ Time Frame: Baseline to 1 week, 1 month, and 3 months post-treatment ]
  • Effect of Targeting Method on Negative Symptoms [ Time Frame: Baseline to 1 week, 1 month, and 3 months post-treatment ]

Central Contacts and Locations

Central contacts

Ashley S. Choucroun

5146593488ashley.choucroun.comtl@ssss.gouv.qc.ca

Locations

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

Recruiting

Verdun, Quebec, Canada, H4H 1R3

Contacts

Ashley Choucroun

5146593488ashley.choucroun.comtl@ssss.gouv.qc.ca

Principal Investigator:

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

More Information

Sponsor

Douglas Mental Health University Institute

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Mental Health University Institute on 2026-08-20.