The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Illness awareness
Study Overview
Brief 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:
- 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.
- 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.
Detailed Description
The proposed study employs a novel approach to determine the clinical and functional imaging effects of CVS 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. CVS is a traditionally safe and non-invasive method of vestibular stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with CVS and illness awareness. The results of this study will provide solid evidence for larger treatment-controlled effectiveness studies to determine if CVS is a practical means of producing lasting effects on illness awareness in individuals with schizophrenia or whether maintenance CVS treatment is required.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Illness awareness
Time Frame: Illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.
Changes in illness awareness will be assessed using questionnaires.
Secondary Outcomes
- Brain network activity(At baseline and post-intervention.)
Investigators
Philip Gerretsen
Principal Investigator
Centre for Addiction and Mental Health