Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)
研究概览
简要总结
The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).
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, 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
- •Clinical and radiological diagnosis of traumatic brain injury.
- •Between one to two years after traumatic brain injuri
- •Must be able to sign the Informed Consent Form
排除标准
- •Drug addiction
- •Uncontrolled epilepsy
- •Extensive Cranial vault defects
研究组 & 干预措施
Active Coil
The patients assigned to this group will undergo repetitive Transcranial Magnetic Stimulation over 10 sessions (each one with 2,000 pulses) on left dorsolateral prefrontal cortex.
干预措施: Active Coil (Other)
Sham
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
干预措施: Sham (Other)
结局指标
主要结局
Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)
时间窗: One week and three months after rTMS.
次要结局
- Changes in cortical excitability measured by single and paired-pulse TMS(one week and three months.)
- Evidence of improvement on Executive Function processes measured by cognitive evaluation.(one week and 3 months.)
- Evidence of improvement on Motor Coordination measured by cognitive evaluation.(one week and three months.)
研究者
Iuri Santana Neville Ribeiro
iurineville
University of Sao Paulo