Cortical Plasticity Assessment in Athletes With a History of Concussion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Cortical excitability and cortical plasticity assessment
研究概览
简要总结
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.
详细描述
This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Transcranial direct current stimulation (Device)
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.
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
Cortical excitability and cortical plasticity assessment
时间窗: Baseline, 1st, 2nd and 3rd week
TMS and tDCS
次要结局
- Cognitive functioning in athletes with concussion compared to athletes without concussion(Baseline, 1st, 2nd and 3rd week)
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital