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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RECRUITING
NA
34 participants
INTERVENTIONAL
2023-10-03
2026-01-30
Brief Summary
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The study device under investigation provides a safe and non-invasive method of brainstem stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with treatment and illness awareness.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Investigational Stimulation Pattern 1-Randomized
Non-invasive brainstem modulation device (stimulation Randomized)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
Investigational Stimulation Pattern 2-Randomized
Non-invasive brainstem modulation device (stimulation Randomized)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
Investigational Stimulation Pattern-Open Label
Non-invasive brainstem modulation device (stimulation-Open Label)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.
Interventions
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Non-invasive brainstem modulation device (stimulation Randomized)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
Non-invasive brainstem modulation device (stimulation-Open Label)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.
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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Centre for Addiction and Mental Health
OTHER
Scion NeuroStim
INDUSTRY
Responsible Party
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Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Phillip Gerretson, MD
Role: primary
Other Identifiers
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SNS-SCZ-001
Identifier Type: -
Identifier Source: org_study_id