- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01220323
Transcranial Direct Current Stimulation for Chronic Pain Relief
연구 개요
상세 설명
tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients.
The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients.
Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm.
Pain will be measured using visual analog scale (VAS) for pain and the short form McGill questionnaire (SF-MPQ). Disability will be measured using the ( Pain Disability Index (PDI) of Life-54 scale (MSQoL-54). Depressive symptoms and anxiety will also be evaluated using the Center for Epidemiological Studies-Depression Scale and the State-trait Anxiety Inventory (STAI). Cognitive function will be mesured using minimental test. Evaluations will be performed at baseline, immediately after the end of treatment, and once a week during a 3-week follow-up period.
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- over 18
- chronic pain patients VAS > 4
Exclusion Criteria:
- pregnancy
- scalp lacerations
- History of seizures
- metal implants in the head
- heart pace maker
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: direct current stimulation
The participants will be divided to 2 groups of 50 each.
One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation.
X week later the groups will switch to the other arm.
|
Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study.
The participants will be divided to 2 groups of 50 each.
One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation.
X week later the groups will switch to the other arm
|
가짜 비교기: 가짜 자극
|
Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study.
The participants will be divided to 2 groups of 50 each.
One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation.
X week later the groups will switch to the other arm
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
통증 완화
기간: 5 일
|
5 일
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Avaluation of tDCS treatment for chronic pain on disability, depression, anxiety, and cognition of treated patients.
기간: 5 days
|
5 days
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
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