Cortical Plasticity Assessment in Athletes With a History of Concussion
The purpose of this research is to determine whether athletes with concussion have changes in cortical excitability.
Single and paired transcranial magnetic stimulation (TMS) can be used as reliable neurophysiological marker of motor cortex reorganization in athletes with concussions.
This study also aims to determine whether modulation of cortical activity by a powerful technique of noninvasive brain stimulation (tDCS) results in a different cortical response as compared with sham tDCS.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国
- Spaulding Rehabilitation Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Student-athletes at risk for traumatic brain injury (collegiate football, ice hockey)
- Age between 18 and 30 yr.
- Concussion as defined by the American Academy of Neurology: trauma-induced alteration in mental status that may or may not involve loss of consciousness (confusion and amnesia are the hallmarks of concussion)
- Concussion that occurred > 6 months
- All head injuries classified as minor with a Glasgow Coma Scale of 13 to 15 at the time of the trauma
- Participants are cleared for full sport participation based upon neurological and neuropsychological (NS) assessments Classified as symptomatic based on Post-concussion Symptom List
Exclusion Criteria:
- Previous significant neurological history
- Use of tricyclic anti-depressants such as amitriptyline, nortriptyline and imipramine within the past six months.
- Use of anticonvulsants such as carbamazepine, phenytoin, valproic acid and gabapentin within the past six months
- History of seizures, depression or PTSD
- Presence of post-concussion symptoms such as complaints of loss of concentration, dizziness, fatigue, headache, irritability, visual disturbances, and light sensitivity.
- Contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants
- history of seizures
- unexplained loss of consciousness
- metal in the head
- frequent or severe headaches or neck pain
- implanted brain medical devices.
- Contraindications to tDCS:
- metal in the head
- implanted brain medical devices
For the control group (subjects with no concussion) we will select subjects according to the previously stated list of exclusions as well as the following criteria: Subjects who are athletes (similar to the concussed group) with the same age range and also similar level of education; however these subjects will have no prior history of concussion or neurological insult as self reported. They should also have no contraindications to TMS or tDCS.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Healthy Subjects
Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized.
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Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.
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实验性的:Athletes with history of concussion
Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized.
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Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cortical excitability and cortical plasticity assessment
大体时间:Baseline, 1st, 2nd and 3rd week
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TMS and tDCS
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Baseline, 1st, 2nd and 3rd week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cognitive functioning in athletes with concussion compared to athletes without concussion
大体时间:Baseline, 1st, 2nd and 3rd week
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Will use the Immediate Postconcussion Assessment and Cognitive Test (IMPACT): a neuropsychological test battery that measures aspects of cognitive functioning including attention, memory, reaction time and information processing speed.
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Baseline, 1st, 2nd and 3rd week
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合作者和调查者
调查人员
- 首席研究员:Felipe Fregni, PhD、Spaulding Rehabilitation Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2010P000191
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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