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| ID | Type | Description | Link |
|---|---|---|---|
| 8401470ASMQ | Other Grant/Funding Number | Alliance Santé Mentale - Axe Neuromodulation | |
| CIHR-8401550 | Other Grant/Funding Number | CIHR |
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| Name | Class |
|---|---|
| Centre de recherche CERVO | UNKNOWN |
| Magnus Medical | INDUSTRY |
| Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Affective Processing | Change in affective processing as measured by performance on a behavioural task assessing conditioned hallucinations related to valenced auditory information. | Baseline to 1 week, 1 month, and 3 months post-treatment |
| Change in Social Appraisal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley S. Choucroun | Contact | ashley.choucroun.comtl@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire en Santé Mentale de Montréal | Not yet recruiting | Montreal | Quebec | H1N 3M5 | Canada |
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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.
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| 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. |
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| 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. |
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Change in social appraisal and belief updating as measured by performance on a behavioral task assessing social inference and valuation. |
| Baseline to 1 week, 1 month, and 3 months post-treatment |
| 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. | Baseline to 1 week, 1 month, and 3 months post-treatment |
| 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. | Baseline to 1 week, 1 month, and 3 months post-treatment |
| 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. | Baseline to 1 week, 1 month, and 3 months post-treatment |
| 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. | Baseline to 1 week, 1 month, and 3 months post-treatment |
| Stéphane Potvin, PhD | Institut Universitaire en Santé Mentale de Montréal | Principal Investigator |
| Lena Palaniyappan, MD, PhD | Douglas Mental Health Institute | Principal Investigator |
| Institut universitaire de santé mentale de Québec - Centre de recherche CERVO | Not yet recruiting | Québec | Quebec | G1J 2G3 | Canada |
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| McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC | Recruiting | Verdun | Quebec | H4H 1R3 | Canada |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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