- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01112761
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.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국
- Spaulding Rehabilitation Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Cortical excitability and cortical plasticity assessment
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cognitive functioning in athletes with concussion compared to athletes without concussion
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Felipe Fregni, PhD, Spaulding Rehabilitation Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2010P000191
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Transcranial direct current stimulation에 대한 임상 시험
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Stanford UniversityNYU Langone Health; Wills Eye; Otto-von-Guericke University Magdeburg모병
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