The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
NCT ID: NCT05957484
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2023-09-12
2025-02-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Treatment
Study participants will receive \~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation 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.
Sham Treatment
Study participants will receive \~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation 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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Scion NeuroStim
INDUSTRY
Centre for Addiction and Mental Health
OTHER
Responsible Party
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Philip Gerretsen
Principal Investigator
Principal Investigators
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Philip Gerretsen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Related Links
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The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.
Other Identifiers
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105-2017
Identifier Type: -
Identifier Source: org_study_id
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