A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.
The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.
Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hongjie Jiang, Dr.
- 전화번호: +86 13777830137
- 이메일: insjhj@zju.edu.cn
연구 장소
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Chongqing, 중국, 400000
- 모병
- Southwest Hospital
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연락하다:
- Jingming Hou, Dr.
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310014
- 모병
- Zhejiang Provincial People's Hospital
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연락하다:
- Ruidong Cheng, Dr.
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Hangzhou, Zhejiang, 중국, 310009
- 모병
- SAHZhejiangU
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연락하다:
- Hongjie Jiang, Dr.
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Hangzhou, Zhejiang, 중국, 310000
- 모병
- Rainbowfish Rehabilitation Nursing Care
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연락하다:
- Ran Wang, Dr.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18-60 year-old
- diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
- cognitive function, perceptual function decline after stroke
- first onset and duration of 3-12 months
- right-handed
- MMSE ≤25
- MoCA ≤25
- sign informed consent voluntarily and comply with the study plan
Exclusion Criteria:
- NIHSS ≥21 points
- MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
- taking drugs that affect central nervous activity, such as nerve antagonists
- specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
- patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
- patients with a previous history of epilepsy, mental illness or skull injury
- patients with dementia or obvious cognitive dysfunction before stroke
- patients with aphasia or dysarthria and cannot complete the scale evaluation
- pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: multi-channel tDCS
In the multi-channel tDCS stimulation group, a 1:4 (anode: cathode) approach was applied, with the central anode placed in the left dorsolateral prefrontal cortex (dlPFC) (reference 10-20 standard lead EEG), and the remaining cathode distributed around the central electrode. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
multi-channel transcranial direct current stimulation, tDCS
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실험적: single-channel tDCS
The anode electrode of the single-channel tDCS stimulation group was placed in the left dlPFC, and the cathode electrode was placed in the right orbital forehead. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
single-channel transcranial direct current stimulation
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가짜 비교기: sham stimulation
The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
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multi-channel transcranial direct current stimulation, tDCS
single-channel transcranial direct current stimulation
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MMSE
기간: Change from Baseline MMSE at 2 weeks and 3 months after intervention
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Mini-mental State Examination
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Change from Baseline MMSE at 2 weeks and 3 months after intervention
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MoCA
기간: Change from Baseline MoCA at 2 weeks and 3 months after intervention
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Montreal Cognitive Assessment
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Change from Baseline MoCA at 2 weeks and 3 months after intervention
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AVLT
기간: Change from Baseline AVLT at 2 weeks and 3 months after intervention
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The Auditory-Verbal Learning Test
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Change from Baseline AVLT at 2 weeks and 3 months after intervention
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WAIS-DST
기간: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
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WAIS Digit Symbol Test
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Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DEX
기간: Change from Baseline DEX at 2 weeks and 3 months after intervention
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Dysexecutive Ques-tionnaire
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Change from Baseline DEX at 2 weeks and 3 months after intervention
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GNAT
기간: Change from Baseline GNAT at 2 weeks and 3 months after intervention
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Go/No-go Association Task
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Change from Baseline GNAT at 2 weeks and 3 months after intervention
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공동 작업자 및 조사자
수사관
- 연구 의자: Hongjie Jiang, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University
- 수석 연구원: Ruidong Cheng, Dr., Zhejiang Provincial People's Hospital
- 수석 연구원: Rang Wang, Dr., Rainbowfish Rehabilitation Nursing Care
- 수석 연구원: Jingming Hou, Dr., Southwest Hospital, China
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .