Neuromodulation for Schizophrenia
Recruiting · NCT05580211 · Interventional (participants receive a specific treatment) · Lead sponsor: Scion NeuroStim
View the official record on ClinicalTrials.gov →Interventions studied
Non-invasive brainstem modulation device (stimulation Randomized)Non-invasive brainstem modulation device (stimulation-Open Label)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
Exclusion criteria
- 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
Where it is running
1 location listed.
- Centre for Addiction and Mental Health - Toronto, Ontario, Canada