Anosognosia, Schizophrenia
Conditions
Keywords
Non-invasive neuromodulation, Illness awareness, Magnetic resonance imaging, Medical device
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: 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.
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.
Interventions
DEVICEInvestigational brainstem neuromodulation device
This study device is non-invasive meaning it stays outside of the body. It stimulates activity in the brain through a headset with metallic earpieces that fit into the participant's ear canals. The device will be loaded with certain neurostimulation pattern, and the earpieces will provide the stimulation at the prescribed pattern.
Sponsors
Scion NeuroStim
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Illness awareness | 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
| Measure | Time frame | Description |
|---|---|---|
| Brain network activity | At baseline and post-intervention. | Assess changes in brain network activity (blood oxygen level dependent-BOLD in response to an illness awareness task) |
Countries
Canada
Outcome results
None listed