The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Reason given: Study device no longer available.
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Trial details
- Who runs it
- Centre for Addiction and Mental Health
- Trial code
- NCT05957484
- Record updated
- 28 March 2025
- Original description
This study aims to determine the clinical and functional imaging effects of serial CVS on illness awareness in schizophrenia. Specifically, the investigators aim to:Read full original descriptionShow less
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
This study aims to determine the clinical and functional imaging effects of serial CVS on illness awareness in schizophrenia. Specifically, the investigators aim to:
1. Determine if twice-daily CVS for 4 weeks will improve illness awareness compared to the sham condition in participants with schizophrenia. Illness awareness will be assessed at pre- and post-CVS, and weekly thereafter for 4 weeks. 2. Examine changes in brain network activity (blood oxygen level dependent-BOLD in response to an illness awareness task) pre- and post-CVS. This will serve as a biomarker to rigorously test whether repeated CVS engages the PPA associated with 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.