Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This study has 2 aims: 1) determine which transcranial direct current stimulation (tDCS) electrode configuration is most effective in combination with motor training to promote motor recovery from severe post-stroke hemiparesis; and 2) begin to clarify the extent to which baseline transcranial magnetic stimulation (TMS) measures predict response to tDCS, as well as the effects of tDCS paired with motor training on TMS measures of motor cortical organization.
To accomplish these aims, the investigators will recruit 36 human subjects with severe post-stroke hemiparesis and assign each subject to 1 of 4 tDCS conditions (anodal excitatory ipsilesional; cathodal inhibitory contralesional; a combination of anodal excitatory ipsilesional during cathodal inhibitory contralesional; or sham). Each subject will undergo a 20-minute stimulation session once a day for 10 days over a 2-week period. Each session will be followed by 3 hours of intensive, task-oriented upper extremity motor training.
Outcome measures for this study include TMS motor cortical maps and standardized tests of motor performance. The investigators hypothesize that all groups will show improvement in all measures; however, both the anodal excitatory ipsilesional group and the cathodal inhibitory contralesional group will show significantly greater improvement compared with the other 2 groups. The investigators will also find evidence clarifying whether the presence or absence of motor-evoked potentials (MEPs) has predictive value regarding which tDCS configuration would be most effective for a particular subject.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Chronic stroke patients
- Single stroke
- Chronic (more than 12 months after from stroke)
- At least 18 years old, but there is no upper age range for this project.
- Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Exclusion Criteria:
- History of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness
- Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
- Cognitive deficit severe enough to preclude informed consent
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Participants with history of untreated depression.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Anodal tDCS with motor training
20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
|
활성 비교기: Cathodal tDCS with motor training
20 minutes of cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
|
활성 비교기: Dual tDCS with motor training
20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere and cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
|
가짜 비교기: Sham tDCS with motor training
20 minutes of sham transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in Fugl Meyer Assessment
기간: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
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Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
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2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in Action Research Arm Test
기간: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
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Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
|
Change in Stroke Impact Scale
기간: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
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Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 11CRP7220009
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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뇌졸중에 대한 임상 시험
Neuroconn Eldith stimulator by Magstim에 대한 임상 시험
-
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