The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Illness Awareness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Illness Awareness
时间窗: 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.
次要结局
- Examine changes in brain network activity(4 weeks from baseline to end of treatment)