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.
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.
Eligibility criteria
Qualifiers
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
Treatments tested in this trial
- Neuronavigated Intermittent Theta Burst Stimulation
- BEAM-F3 Intermittent theta burst stimulation
- Sham Intermittent Theta Burst Stimulation
Treatment groups
Sponsors and collaborators
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