An interventional study of Neuronavigated Intermittent Theta Burst Stimulation and BEAM-F3 Intermittent theta burst stimulation in Schizophrenia and Predominant Negative Symptoms, sponsored by Douglas Mental Health University Institute. Recruiting at 3 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Douglas Mental Health University Institute · Not applicable, Interventional, and Treatment
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 75 is close to the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Douglas Mental Health University Institute is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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 (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 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Affective Processing
Change in affective processing as measured by performance on a behavioural task assessing conditioned hallucinations related to valenced auditory information.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Social Appraisal
Change in social appraisal and belief updating as measured by performance on a behavioral task assessing social inference and valuation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
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Douglas Mental Health University Institute