Schizophrenia
Conditions
Keywords
neuromodulation
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.
Interventions
DEVICENon-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.
DEVICENon-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.
Sponsors
Centre for Addiction and Mental Health
Scion NeuroStim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Illness Awareness | 4 weeks from baseline to end of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examine changes in brain network activity | 4 weeks from baseline to end of treatment | functional MRI blood oxygen level dependent (BOLD) in response to an illness awareness task pre- and post-treatment. This will serve as a biomarker to rigorously test whether repeated treatment engages the posterior parietal area of the brain associated with illness awareness. |
Countries
Canada
Contacts
Primary ContactPhillip Gerretson, MD
Outcome results
None listed