Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
研究概览
简要总结
OBJECTIVES:
I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of two treatment arms.
Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends.
Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. The total duration of sham stimulation is 132 minutes. Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends.
This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
时间窗: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline
次要结局
- Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions(After the 9th active/sham rTMS session (up to 2 weeks or end of intervention))
- Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions(After the 9th active/sham rTMS session (up to 2 weeks or end of intervention))
- Responder Status(After the 9th active/sham rTMS session (up to 2 weeks or end of intervention))