| NCT ID | NCT05580211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Scion NeuroStim |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2023-10-03 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2023-10-03 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05580211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05580211 currently recruiting?
Yes, NCT05580211 is actively recruiting participants. Contact the research team at Philip.Gerretsen@camh.ca for enrollment information.
Where is the NCT05580211 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05580211 clinical trial?
NCT05580211 is sponsored by Scion NeuroStim. The trial plans to enroll 34 participants.
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