Targeting Auditory Hallucinations With Alternating Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score
研究概览
简要总结
Investigating the effects of non-invasive transcranial current stimulation as a treatment for auditory hallucinations in patients with schizophrenia.
详细描述
The investigator's primary objective is to conduct a pilot clinical trial to establish the feasibility and to collect first effectiveness data for the use of transcranial alternating current stimulation (tACS) to re-normalize pathological alpha oscillations in dorso-lateral prefrontal cortex (dl-PFC) of patients with schizophrenia or schizoaffective disorder by comparing Auditory Hallucination Rating Scale (AHRS) scores immediately before the first stimulation session and immediately after the last stimulation session. As a secondary objective the investigators will assess the differential clinical effects of sham, 10 Hz and 2 mA transcranial direct current stimulation (tDCS) on electroencephalogram (EEG) measures of alpha oscillations.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year
- •18-70 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 at least 4 weeks
- •Stable auditory hallucinations as demonstrated by having less than or equal to 20% change in AHRS scores across a 2 week interval during the screening period.
- •Capacity to understand all relevant risks and potential benefits of the study and to provide written informed consent, OR has a legal guardian who can provide informed consent on the patient's behalf with the patient providing written assent to participate.
排除标准
- •DSM-IV diagnosis of alcohol of 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
- •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
- •History of traumatic brain injury that required subsequent cognitive rehabilitation, or caused cognitive sequelae
- •Prior brain surgery
- •Any brain devices/implants, including cochlear implants and aneurysm clips
- •Co-morbid neurological condition (e.g. seizure disorder, brain tumor)
- •Non English speakers
- •Female participants who are pregnant, nursing, or unwilling to use an adequate method of contraception during study participation for those of childbearing potential
- •Positive urine test for cannabis, cocaine, amphetamine, barbiturates, benzodiazepines, opiates
研究组 & 干预措施
tACS (alpha)
20 participants: 10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily
干预措施: tACS (alpha) (Device)
tDCS
20 participants: 2mA stimulation for 20 minutes twice daily
干预措施: tDCS (Device)
Sham stimulation
20 participants: Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.
干预措施: tACS (alpha) (Device)
结局指标
主要结局
Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score
时间窗: Baseline, five days post baseline, 2 weeks post baseline, 5 weeks post baseline
The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assesses frequency, duration, location, loudness, belief of origin of voices, negative content, distress, disruption to life, and control over voices. All items are measured on a scale of 0 to 4, with a total possible score of 44. Higher scores indicate higher severity of auditory hallucinations. The investigators will compare the AHRS scores from immediately before the first stimulation and immediately after the last stimulation session as the investigator's primary outcomes measure.
次要结局
- Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline(Baseline, five days post baseline)
- Change in Positive and Negative Syndrome Scale (PANSS) Scores(baseline, five days post baseline, five weeks post baseline)
- Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State(Baseline, five days post baseline)
- Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score(baseline, five days post baseline, five weeks post baseline)