Neuromodulation for Schizophrenia
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
1 other identifier
interventional
34
1 country
1
Brief Summary
Our proposed study employs a novel approach to determine the clinical and functional imaging effects of brainstem neuromodulation, with an investigational study device, 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedStudy Start
First participant enrolled
October 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedDecember 17, 2024
December 1, 2024
2.1 years
October 11, 2022
December 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Illness Awareness
functional MRI paradigm. The paradigm consists of a bank of brief questions or statements to which participants respond either "yes/agree" or "no/disagree". The brief statements are derived from four categories: general illness awareness, symptom awareness and attribution, awareness of need for treatment, and illness independent/control.
4 weeks from baseline to end of treatment
Secondary Outcomes (1)
Examine changes in brain network activity
4 weeks from baseline to end of treatment
Study Arms (3)
Investigational Stimulation Pattern 1-Randomized
OTHERInvestigational Stimulation Pattern 2-Randomized
OTHERInvestigational Stimulation Pattern-Open Label
OTHERInterventions
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
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
You may qualify if:
- 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
You may not qualify if:
- 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
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scion NeuroStimlead
- Centre for Addiction and Mental Healthcollaborator
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- During the Phase I, all participants are randomized to one of two treatment stimulation patterns. In Phase II, all participants will receive the same treatment pattern.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2022
First Posted
October 14, 2022
Study Start
October 3, 2023
Primary Completion
October 30, 2025
Study Completion
January 30, 2026
Last Updated
December 17, 2024
Record last verified: 2024-12