The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Study Details
Study Description
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:
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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.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Treatment Study participants will receive ~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device. |
Device: Investigational 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.
|
| Placebo Comparator: Sham Treatment Study participants will receive ~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device. |
Device: Investigational 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.
|
| Experimental: Open Label 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. |
Device: Investigational 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female inpatients or outpatients ≥ 18 years of age
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Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder
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Voluntary and capable of consenting to participation in the research study
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Fluent in English
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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)
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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:
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Unwilling or unable to consent to the study
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Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
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Had eye surgery within the previous three (3) months
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Ear surgery within 6 months prior to entering the study
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Active ear infection or perforated tympanic membrane
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Diagnosis of vestibular dysfunction
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Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures
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Acute suicidal and/or homicidal ideation
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Formal thought disorder rating ≥4 on PANSS item P2
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DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study
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Positive urine drug screen at the screening visit
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Metal implants or a pacemaker that would preclude the MRI scan
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Addiction and Mental Health | Toronto | Ontario | Canada | M5T 1R8 |
Sponsors and Collaborators
- Centre for Addiction and Mental Health
- Scion NeuroStim
Investigators
- Principal Investigator: Philip Gerretsen, MD, PhD, Centre for Addiction and Mental Health
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 105-2017