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New treatment option for Schizophrenia
Official title Neuromodulation for Schizophrenia
ClinicalTrials.gov ID: NCT05580211
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Unwilling or unable to consent to the study
- Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
- Had eye surgery within the previous three (3) months
- Ear surgery within 6 months prior to entering the study
- Active ear infection or perforated tympanic membrane
- Diagnosis of vestibular dysfunction
See the full eligibility criteria
- 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
- Unwilling or unable to consent to the study
- Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
- Had eye surgery within the previous three (3) months
- Ear surgery within 6 months prior to entering 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
- DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study
- Positive urine drug screen at the screening visit
- Metal implants or a pacemaker that would preclude the MRI scan
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.