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
- 1
- 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
- •PROTOCOL ENTRY CRITERIA:
- •Inclusion criteria:
- •Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
- •Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
- •Right-handed
- •At least 4 weeks on stable antipsychotic medication
排除标准
- •history of seizure (unless due to drug withdrawal or medication that is no longer prescribed)
- •history of epilepsy in first degree relatives
- •estimated IQ less than 80
- •unable to provide informed consent
- •significant unstable medical condition
- •current treatment with clozapine or bupropion
- •cochlear implants or other metal in the head (surgical, etc.)
- •history of cardiac arrhythmia
- •cardiac pacemaker
- •active drug or alcohol abuse within prior 6 weeks
- •pregnancy
研究组 & 干预措施
active rTMS
1-Hz rTMS delivered to left temporoparietal cortex at 90% motor threshold for 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)
干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)
sham stimulation
Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)
干预措施: sham stimulation (Device)
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))