The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Scion NeuroStim
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Illness Awareness
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Illness Awareness
Time Frame: 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 Outcomes
- Examine changes in brain network activity(4 weeks from baseline to end of treatment)