Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia (NCT07428460) | Clinical Trial Compass
RecruitingNot Applicable
Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
Canada75 participantsStarted 2026-02-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Avolition/Apathy Subscale Score
Timeframe: Baseline to 1 week, 1 month, and 3 months post-treatment
2
Change in Scale for the Assessment of Negative Symptoms Total Score
Timeframe: Baseline to 1 week, 1 month, and 3 months post-treatment
3
Change in Brief Negative Symptom Scale Total Score
Timeframe: Baseline to 1 week, 1 month, and 3 months post-treatment
4
Effect of Targeting Method on Negative Symptoms
Timeframe: Baseline to 1 week, 1 month, and 3 months post-treatment