The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Schizophrenia, Anosognosia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Non-invasive neuromodulation, Illness awareness, Magnetic resonance imaging, Medical device
Eligibility Criteria
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
Sites / Locations
- Centre for Addiction and Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
Experimental
Active Treatment
Sham Treatment
Open Label
Study participants will receive ~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device.
Study participants will receive ~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device.
After completion of sham or active stimulation over 4 weeks, participants can choose to receive ~18-minute active stimulation twice daily for up to 12 weeks.