Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Brainsway
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- cognitive functioning score by ADAS-COG
研究概览
简要总结
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
详细描述
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.
Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2
Ages: 50-85 Genders: both
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 50-
- •Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
- •Scored below 24 on the MMSE.
- •Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
- •Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
- •Gave their oral and written consent to participate in the trial.
排除标准
- •An additional neurological or psychiatric disorder.
- •Severe personality disorder.
- •Uncontrolled hypertension.
- •History of epilepsy, seizure, or heat convulsion.
- •History of epilepsy or seizure in first degree relatives.
- •History of head injury or stroke.
- •History of metal implants in the head (except dental fillings).
- •History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps.
- •History of migraines in the last six months.
- •History of drug or alcohol abuse.
- •Inadequate communication with examiner.
- •Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
- •Inability to sign a consent form.
研究组 & 干预措施
TMS, High Frequency
High Frequency TMS with H coil to prefrontal cortex
干预措施: TMS, H coil (Device)
TMS, Low Frequency
Low Frequency TMS to Prefrontal cortex
干预措施: TMS, H coil (Device)
Sham Stimulation
Sham TMS with H Coil on Prefrontal Cortex
干预措施: TMS, H coil (Device)
结局指标
主要结局
cognitive functioning score by ADAS-COG
时间窗: 4 months
次要结局
- Global advancement score by CGI-C(4 months)
- Frontal lobe functioning score by FAB(4 months)
- Daily activity score by ADL(4 months)