The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia (NCT05957484) | Clinical Trial Compass
TerminatedNot Applicable
The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Stopped: Study device no longer available.
Canada4 participantsStarted 2023-09-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
✕
What they're measuring
1
Illness awareness
Timeframe: Illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.