Testing a non-invasive brainstem device for illness awareness in schizophrenia
Tests a non-invasive brainstem stimulation device in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: Neuromodulation for Schizophrenia
Key facts
- Where
- Toronto, CanadaSee the site
Where in Canada
- Centre for Addiction and Mental HealthToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Scion NeuroStim
- Trial code
- NCT05580211
- Record updated
- 17 December 2024
- Original description
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.Read full original descriptionShow less
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
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.
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: Had eye surgery within the previous three (3) months; Ear surgery within 6 months prior to entering the study; Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures; 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; Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease; Active ear infection or perforated tympanic membrane; Formal thought disorder rating ≥4 on PANSS item P2; Unwilling or unable to consent to the study; Diagnosis of vestibular dysfunction; Acute suicidal and/or homicidal ideation; Pregnancy.