Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDouglas Mental Health University Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neuronavigated Intermittent Theta Burst Stimulation
DeviceNeuronavigated 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
DeviceBEAM-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
DeviceSham 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Active iTBS (Neuronavigated Targeting)Experimental treatment 1 intervention
Group B: Active iTBS (BEAM-F3 Targeting)Experimental treatment 1 intervention
Group C: Sham iTBSSham comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline to 1 week, 1 month, and 3 months post-treatment2
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-treatment3
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-treatment4
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-treatmentSecondary outcomes
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.
Time frame
Baseline to 1 week, 1 month, and 3 months post-treatment2
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-treatment3
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-treatment4
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-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Douglas Mental Health University Institute
Lead sponsor
Centre de recherche CERVO
Collaborator
Magnus Medical
Collaborator
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborator
Source ClinicalTrials.gov