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RECRUITINGINTERVENTIONAL

Neuromodulation for Schizophrenia

The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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.

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.

Locations (1)

Centre for Addiction and Mental Health
Toronto, Ontario, Canada