Comparing 3 approaches for schizophrenia
Official title: Neuromodulation for Schizophrenia
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Interventions
Non-invasive brainstem modulation device (stimulation Randomized)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
Non-invasive brainstem modulation device (stimulation-Open Label)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.
Canadian Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female inpatients or outpatients ≥ 18 years of age
- +Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder
- +Voluntary and capable of consenting to participation in the research study
- +Fluent in English
- +Moderate-to-severe lack of illness awareness ≤7 on the VAGUS-SR, which corresponds to a rating of ≥3 on PANSS G12 Insight and Judgment item
- +On a stable dose of antipsychotic and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study
Exclusion
- −Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
- −Unwilling or unable to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to the study
- −Active ear infection or perforated tympanic membrane
- −Diagnosis of vestibular dysfunction
- −Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures
- −Acute suicidal and/or homicidal ideation
- −Formal thought disorder rating ≥4 on PANSS item P2
- −Positive urine drug screen at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Metal implants or a pacemaker that would preclude the MRI scan
- −Had eye surgery within the previous three (3) months
- −Ear surgery within 6 months prior to entering the study
- −DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Non-invasive brainstem modulation device (stimulation RandomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →), Non-invasive brainstem modulation device (stimulation-Open LabelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 34 people.
The study is currently expected to finish around January 2026.
The main measurement is taken over: 4 weeks from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to end of treatment.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Illness Awareness — measured over 4 weeks from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to end of treatment.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05580211 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Non-invasive brainstem modulation device (stimulation Randomized)Device
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Non-invasive brainstem modulation device (stimulation-Open Label)Device
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 4 weeks from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to end of treatment.
The study as a whole is currently expected to finish around 2026-01-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 34 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Our proposed study employs a novel approach to determine the clinical and functional imaging effects of brainstem neuromodulation, with an investigational study device, on illness awareness in schizophrenia - a significant contributor to medication non-adherence and poor treatment outcomes, and arguably the most treatment resistant manifestation of the disorder. The study device under investigation provides a safe and non-invasive method of brainstem stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with treatment and illness awareness.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.