Clinical Trial to Assess Transcranial Current Stimulation as a Treatment for Medication Refractory Auditory Hallucinations in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5
研究概览
简要总结
Investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.
详细描述
AIM 1: To evaluate the effect of transcranial direct current stimulation (tDCS) (2mA for 20min on five consecutive days) on auditory hallucinations in schizophrenia patients using the change in ratings on the Auditory Hallucination Rating Scale (AHRS) by patients before and after stimulation. We hypothesize that tDCS will modulate the abnormal neuronal activity found in schizophrenic patients and thereby decrease their auditory hallucinations when measured after stimulation.
AIM 2: To evaluate the long term effects of tDCS by having patients give a rating on the AHRS after one month has passed since stimulation and comparing this value to their baseline score and their score immediately after stimulation. We hypothesize that there will remain a significant reduction in auditory hallucination score in participants who received tDCS at one month.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year.
- •18-99 years old.
- •Clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care .
- •On current antipsychotic doses for approximately 4 weeks or more.
- •Capacity to understand all relevant risks and potential benefits of the study (informed consent) OR has a legal guardian who can complete consent forms on the patients behalf
- •Right handed
排除标准
- •Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months.
- •History of significant head injury/trauma, as defined by loss of consciousness for more than 1 hour, or recurring seizures, or requiring later cognitive rehabilitation or causing cognitive sequelae.
- •Prior brain surgery.
- •Any brain devices/implants, including cochlear implants and aneurysm clips.
- •Co-morbid neurological condition (i.e. seizure disorder, brain tumor).
- •Medical or neurological illness (unstable cardiac disease AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation.
- •Non English speakers.
- •Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
结局指标
主要结局
Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5
时间窗: Baseline, Day 5
Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.
次要结局
- Persistence of Decrease in AHRS Score Over Time(Day 5, One month)
研究者
Flavio Frohlich, PhD
Assistant Professor, Departments of Psychiatry, Cell Biology and Physiology, and Biomedical Engineering
University of North Carolina, Chapel Hill