Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change of Fugl-Meyer Assessment (FMA)
研究概览
简要总结
Low-frequency navigated repetitive transcranial magnetic stimulation (nrTMS) of the non-damaged hemisphere to increase cortical excitability of the damaged hemisphere and to reduce the increased neuronal inhibition in patients suffering from new surgery-related paresis after brain tumor resection
详细描述
Postoperative loss of motor function greatly impairs the patients' quality of life and life expectancy of patients with brain tumors is significant limited. Hence the reduction of time spent on neurorehabilitation is very important.
Inclusion of patients that underwent brain tumor resection with a surgery-related paresis of the upper extremity.
Randomized controlled and double blinded trial - 2/3 nrTMS, 1/3 sham. Fifteen minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days: nrTMS group or sham group. Thirty minutes physical therapy of the upper extremity in both groups.
MRI, nTMS motor mapping, assessments for motor status of upper extremity including Fugl-Meyer-Assessment (FMA), National Institution of Health Stroke Scale (NIHSS), Jebsen Taylor Hand Function Test (JTHFT), Nine Hole Peg Test (NHPT), and Karnofsky Performance Scale (KPS) postoperatively, after the 7th day of intervention and after 3 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New surgery-related paresis of upper extremity after brain tumor resection
- •Written informed consent for participation
排除标准
- •Contraindications for MRI
- •Contraindications for nrTMS
- •Only biopsy instead of tumor resection
- •Patients without preserved MEP response as measured by postoperative nTMS motor mapping
结局指标
主要结局
Change of Fugl-Meyer Assessment (FMA)
时间窗: Between first day of intervention and 3-months follow up
Assessment upper extremity
次要结局
- Jebsen Taylor Hand Function Test (JTHFT)(First day of intervention = postoperatively, after the 7th day of intervention and after 3 months)
- Nine Hole Peg Test (NHPT)(First day of intervention = postoperatively, after the 7th day of intervention and after 3 months)
- Karnofsky Performance Status (KPS)(First day of intervention = postoperatively, after the 7th day of intervention and after 3 months)
- National Institutes of Health Stroke Scale (NIHSS)(First day of intervention = postoperatively, after the 7th day of intervention and after 3 months)
研究者
Sandro M. Krieg
Attending Neurosurgeon
Technical University of Munich