The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI
The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Seoul, 대한민국, 03080
- Seoul National University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20<=age<90
- neuropathic pain (LANSS score >= 12), stable chronic pain for at least the three preceding months but not over 5 years
- score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (VAS) for pain perception at the baseline/start of the treatment
- refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months)
- informed consent
Exclusion Criteria:
- patients with any clinically significant or unstable medical or progressive neurologic disorder
- contraindication for electrial stimulation such as pacemaker implant
- Women of childbearing age or pregnancy
- significant cognitive deficit
- Syringomyelia
- neuropsychiatric comorbidity
- depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory)
- history of substance abuse
- skin defect under the electrodes
- progressive neurological disease or other secondary conditions that could impact neuropathic pain
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: tsDCS
In the tsDCS group, anodal tsDCS will be applied for 20 minutes.
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Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany). In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system) In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.
다른 이름들:
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위약 비교기: sham
In sham tsDCS group, the current of anodal tsDCS will be discontinued after 30 s while the power indicator remained on for 20 minutes.
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Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany). In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system) In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Numeric rating scale (NRS) for neuropathic pain
기간: Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation
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On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable
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Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient Global Assessment (PGA)
기간: Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation
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One of the most widely used patient reported outcomes (PROs) & PGA reflects the global impact of the disease from the patient's perspective
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Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation
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Present Pain Intensity (PPI)
기간: Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation
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Patient's subjective feeling of the intensity of pain right now 0: No pain
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Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.
- Ngernyam N, Jensen MP, Arayawichanon P, Auvichayapat N, Tiamkao S, Janjarasjitt S, Punjaruk W, Amatachaya A, Aree-uea B, Auvichayapat P. The effects of transcranial direct current stimulation in patients with neuropathic pain from spinal cord injury. Clin Neurophysiol. 2015 Feb;126(2):382-90. doi: 10.1016/j.clinph.2014.05.034. Epub 2014 Jun 21.
- Cogiamanian F, Vergari M, Schiaffi E, Marceglia S, Ardolino G, Barbieri S, Priori A. Transcutaneous spinal cord direct current stimulation inhibits the lower limb nociceptive flexion reflex in human beings. Pain. 2011 Feb;152(2):370-375. doi: 10.1016/j.pain.2010.10.041. Epub 2010 Dec 14.
- Parazzini M, Fiocchi S, Liorni I, Rossi E, Cogiamanian F, Vergari M, Priori A, Ravazzani P. Modeling the current density generated by transcutaneous spinal direct current stimulation (tsDCS). Clin Neurophysiol. 2014 Nov;125(11):2260-2270. doi: 10.1016/j.clinph.2014.02.027. Epub 2014 Apr 3.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
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