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Schizophrenia and Predominant Negative SymptomsTMSNSNCT07428460

Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

A study testing Neuronavigated Intermittent Theta Burst Stimulation and BEAM-F3 Intermittent theta burst stimulation in people with Schizophrenia and Predominant Negative Symptoms, run by Douglas Mental Health University Institute at 3 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Neuronavigated Intermittent Theta Burst Stimulation and BEAM-F3 Intermittent theta burst stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
3 sitesCanada
Study dates
1 Feb 2026to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Canada3 sites, 3 recruiting
  • Institut Universitaire en Santé Mentale de Montréal

    Montreal, Quebec, H1N 3M5

    Stéphane Potvin, PhD, (514) 251-4015, stephane.potvin@umontrela.ca

    Stéphane Potvin, PhD

    Not yet recruiting
  • Institut universitaire de santé mentale de Québec - Centre de recherche CERVO

    Québec, Quebec, G1J 2G3

    Olivier Roy Roy, MD, MSc, PhD, FRCPC, 418-663-5000 ext. 24615, olivier.roy@cervo.ulaval.ca

    Olivier Roy, MD, MSc, PhD, FRCPC

    Not yet recruiting
  • McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC

    Verdun, Quebec, H4H 1R3

    Ashley Choucroun, 5146593488, ashley.choucroun.comtl@ssss.gouv.qc.ca

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

    Recruiting

Other trials in Canada

About this study

Official title: Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

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.

Read more

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.

Read the detailed description

Negative symptoms of schizophrenia, including diminished motivation, reduced emotional expression, and impaired social functioning, are a major contributor to long-term disability and remain inadequately treated by existing interventions. Repetitive transcranial magnetic stimulation targeting the left dorsolateral prefrontal cortex has demonstrated potential benefit for negative symptoms, but conventional treatment schedules often require multiple weeks of daily sessions, which may limit feasibility in this population.

Accelerated neuromodulation therapy delivers multiple stimulation sessions per day over a condensed time period and may improve accessibility, adherence, and tolerability. This pilot study evaluates an accelerated iTBS protocol delivered over five consecutive days in individuals with schizophrenia spectrum disorders who exhibit clinically significant negative symptoms.

Participants are randomized to receive either active neuromodulation therapy or sham stimulation. In addition, the study evaluates two approaches to stimulation targeting. Targeting approach is assigned according to study procedures designed to preserve participant and rater blinding.

All participants undergo baseline clinical, behavioral, and functional assessments, followed by the accelerated treatment protocol and post-treatment follow-up assessments. Primary outcomes focus on changes in negative symptom severity, while secondary outcomes assess depressive symptoms, functional outcomes, and task-based behavioral measures.

Being tested
Neuronavigated Intermittent Theta Burst Stimulation, BEAM-F3 Intermittent theta burst stimulation, Sham Intermittent Theta Burst Stimulation
Keywords
Negative symptoms, Neuromodulation therapy, Non-invasive brain stimulation, Accelerated treatment, Schizophrenia spectrum disorders, TMS, Transcranial Magnetic Stimulation, Outpatient treatment
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuronavigated Intermittent Theta Burst StimulationDevice

    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 stimulationDevice

    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 StimulationDevice

    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.

Study groups in NCT07428460
Study groupRoleWhat they receive
Active iTBS (Neuronavigated Targeting)ExperimentalParticipants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using neuronavigation-guided targeting.
Receives: Device: Neuronavigated Intermittent Theta Burst Stimulation
Active iTBS (BEAM-F3 Targeting)ExperimentalParticipants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using BEAM-F3 targeting.
Receives: Device: BEAM-F3 Intermittent theta burst stimulation
Sham iTBSSham comparatorParticipants receive sham iTBS over five consecutive days (ten sessions/day) using the same session structure and procedures as active treatment.
Receives: Device: Sham Intermittent Theta Burst Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. Effect of Targeting Method on Negative Symptoms

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

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

Secondary outcomes (6)
  1. Change in Affective Processing

    Change in affective processing as measured by performance on a behavioural task assessing conditioned hallucinations related to valenced auditory information.

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

  2. Change in Social Appraisal

    Change in social appraisal and belief updating as measured by performance on a behavioral task assessing social inference and valuation.

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

  3. Change in Cognitive Performance

    Change in cognitive performance as measured by an automated cognitive battery assessing attention, processing speed, working memory, verbal memory, verbal fluency, and executive function.

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

  4. Change in Montgomery-Åsberg Depression Rating Scale Score

    Change in score on the Montgomery-Åsberg Depression Rating Scale. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity.

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

  5. Change in Calgary Depression Scale for Schizophrenia Score

    Change in score on the Calgary Depression Scale for Schizophrenia. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.

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

  6. Change in Social and Occupational Functioning Assessment Scale Score

    Change in score on the Social and Occupational Functioning Assessment Scale. Scores range from 0 to 100, with higher scores indicating better functioning.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start1 Feb 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07428460
Sponsor's protocol ID
MP-18-2025-1206
Other IDs
8401470ASMQ, CIHR-8401550
Acronym
TMSNS
Status last verified
Aug 2026
First submitted
12 Feb 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Neuronavigated Intermittent Theta Burst Stimulation and BEAM-F3 Intermittent theta burst stimulation in people with Schizophrenia and Predominant Negative Symptoms, run by Douglas Mental Health University Institute at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ashley S. Choucroun (5146593488, ashley.choucroun.comtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Avolition/Apathy Subscale Score (time frame: Baseline to 1 week, 1 month, and 3 months post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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