Brainstem stimulation for improving awareness in schizophrenia
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
NA · Scion NeuroStim · NCT05580211
This study tests if a new brain stimulation device can help people with schizophrenia become more aware of their illness and stick to their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scion NeuroStim (industry) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05580211 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a non-invasive brainstem neuromodulation device on illness awareness in patients with schizophrenia. By utilizing a novel approach that combines brain stimulation with neuroimaging biomarkers, the study aims to assess changes in brain function associated with treatment. The goal is to address the significant issue of medication non-adherence linked to lack of illness awareness, which is a challenging aspect of schizophrenia management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of schizophrenia or schizoaffective disorder who exhibit moderate-to-severe lack of illness awareness.
Not a fit: Patients with stable medical conditions or those who have undergone recent ear or eye surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment adherence and overall outcomes for patients with schizophrenia.
How similar studies have performed: While the approach of brainstem neuromodulation is innovative, similar studies exploring neuromodulation techniques have shown promise in other psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female inpatients or outpatients ≥ 18 years of age 2. Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder 3. Voluntary and capable of consenting to participation in the research study 4. Fluent in English 5. 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 6. 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: 1. Unwilling or unable to consent to the study 2. Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease 3. Had eye surgery within the previous three (3) months 4. Ear surgery within 6 months prior to entering the study 5. Active ear infection or perforated tympanic membrane 6. Diagnosis of vestibular dysfunction 7. Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures 8. Acute suicidal and/or homicidal ideation 9. Formal thought disorder rating ≥4 on PANSS item P2 10. DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study 11. Positive urine drug screen at the screening visit 12. Metal implants or a pacemaker that would preclude the MRI scan 13. Pregnancy
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Phillip Gerretson, MD
- Email: Philip.Gerretsen@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia, neuromodulation