Transcranial Electrical Stimulation With Special Waveform for Upper Extremity Rehabilitation for Patients With Stroke
2021년 4월 12일 업데이트: Taipei Medical University
Transcranial electrical stimulation (tCES) is contemporarily important issues in the advanced rehabilitation medicine.
tCES can selectively change the excitability of regional cortex with non-invansive and safety properties.
Therefore, the investigators aim to develop a set of tCES system with special waveforms for using in clinical rehabilitation of upper extremities.
This developed tCES system is smaller than all commercial available products, which could be conveniently and portably wore on head for clinical rehabilitation.
In addition, the present tCES system with special waveforms developing by the investigators is much more efficient on improving neuroplasticity than the traditional transcranial direct current stimulation (tDCS) in rats.
The investigators hope the tCES system combined with the rehabilitation of body extremities will become a routine treatment for stroke patients at hospitals or residential rehabilitation in the future.
연구 개요
상세 설명
Transcranial direct current stimulation (tDCS) and intermittent theta burst stimulation (iTBS) were both demonstrated to have therapeutic potentials to rapidly induce neuroplastic effects in various rehabilitation training regimens. Recently, the investigators have developed a novel transcranial electrostimulation device that can flexibly output an electrical current with combined tDCS and iTBS waveforms. However, limited studies have determined the therapeutic effects of this special waveform combination on clinical rehabilitation. Herein, the investigators aiming to brain stimulation effects of tDCS-iTBS on upper-limb motor function in chronic stroke patients.
Twenty-four subjects with a chronic stroke were randomly assigned to a real non-invasive brain stimulation (NIBS; subjects received the real tDCS+iTBS output) group or a sham NIBS (subjects received sham tDCS+iTBS output) group. All subjects underwent 1 h treatment of a conventional rehabilitation program (3 days a week for 6 weeks), where a 20-min NIBS intervention was simultaneously applied during conventional rehabilitation. Outcome measures were assessed before and immediately after the intervention period: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Jebsen-Taylor Hand Function Test (JTT), and Finger-to-Nose Test (FNT).
연구 유형
중재적
등록 (실제)
24
단계
- 해당 없음
연락처 및 위치
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연구 장소
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Taipei city, 대만
- Taipei Medical University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age ≥ 20 years.
- Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Adequate understanding of verbal/written information and physically able to complete the motor learning of functional tasks with the affected hand.
Exclusion Criteria:
- Extremely sensitive to electrical stimulation and cannot tolerate it.
- Contracture on upper extremities, and limitation in joint range of motion.
- The muscle tone was severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of cardiopulmonary disease or arrhythmia.
- With implantable medical electronic devices, like pacemaker.
- Pressure sores or wounds on the skin of head and upper extremities.
- Metal implants in the head (neck).
- Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
- A history of seizure or other brain pathology.
- Brain surgery or severe brain trauma.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: tCES & upper extremity rehabilitation
The experiment group will receive tCES combined with upper extremity rehabilitation of affected side.
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The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms.
tCES will be applied for 20 minutes at an intensity of 1.0 -1.5 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 6 weeks.
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가짜 비교기: Sham tCES & upper extremity rehabilitation
The sham control group will receive sham tCES combined with upper extremity rehabilitation of affected side.
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The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms.
Sham tCES will consist of a 5-second ramp up to 1.0-1.5 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
기간: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The FMA-UE was performed (score ranges from 0 to 66) to assess upper limb motor recovery.
Each movement is estimated by a 3-point scale (0-1-2).
The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
기간: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The JTT assesses hand functions commonly used in activities of daily living.
The subtests are scored according to time taken to complete the task.
Total score is the sum of time taken for each subtest, with shorter times indicating better performance.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Change from baseline in the Finger to Nose Test after intervention
기간: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The Finger to Nose Test assesses coordination of upper-extremity movement.
The number of complete nose-target movements during a 1 min period will be recorded.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Modified Ashworth scale (MAS) measures
기간: Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Chi-Wei Peng, Ph.D., School of Biomedical Engineering, Taipei Medical University
간행물 및 유용한 링크
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 3월 2일
기본 완료 (실제)
2020년 1월 31일
연구 완료 (실제)
2020년 4월 30일
연구 등록 날짜
최초 제출
2020년 4월 27일
QC 기준을 충족하는 최초 제출
2020년 4월 27일
처음 게시됨 (실제)
2020년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 12일
마지막으로 확인됨
2020년 4월 1일
추가 정보
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