- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02195271
Neuroplasticity:Melatonin and Transcranial Current Stimulation in Healthy Subjects.
Effect of Melatonin and Transcranial Direct Current Stimulation (tDCS) on Neuroplasticity and the Heat-pain Detection Threshold in Healthy Subjects:Randomized, Double-blind,Crossover Trial
Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is is associated with a wide range of diseases and their social consequences is a public health problem.
With the progress of neuroscience and studies on the plasticity of the central nervous system, it has been provided a better understanding of the neurobiological mechanisms of pain.
The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both in physiological and pathological situations, with modulating effects on the process of nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and GABAergic, exerting anti-inflammatory action, analgesic activity among others.
The advent of neuromodulation techniques such as transcranial direct current stimulation (tDCS), which promote changes in neuronal activity and signaling to be effective in conditions of chronic pain by attenuating changes in cortical excitability.
There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus, considering the potential for each isolated intervention and the lack of knowledge of their combined effect, the authors propose the present study to investigate the effect of this combination on the heat-pain detection threshold and the neuroplasticity in the healthy subjects.
연구 개요
상세 설명
The methods are according to the CONSORT guidelines.
Heat pain threshold and tolerance : Quantitative Sensory Testing (QST) will be used on a computer Peltier-based device thermode.
Conditioned Pain Modulation (CPM)-task: Immerssing the non-dominant hand cold water for 1 minute.
Serum Brain Derived Neurotrophic Factor (BDNF).
Transcranial Magnetic Stimulation (TMS) assessment: motor threshold, motor evoked potential, Short intracortical inhibition and intracortical facilitation.
Statistical analyses: Descriptive statistics, Linear and multiple regression analysis, performed with SPSS version18.0.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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RS
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Porto Alegre, RS, 브라질, 900035-903
- 모병
- Hospital de Clinicas de Porto Alegre
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연락하다:
- Wolnei Caumo
- 전화번호: 555133590083
- 이메일: caumo@cpovo.net
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부수사관:
- Nadia Jardim, MD, Msc
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male 18-40 years old
- Healthy
- Without medication
- Sign the informed consent
Exclusion Criteria:
- Patients who did not understand the Portuguese
- Acute or chronic pain conditions
- Medical or psychiatric disorders
- History of alcohol or substance abuse
- Neurological disorder
- Use of medications affect in the central nervous system
- Traumatic brain injury
- Neurosurgery
- Metallic implant in the brain
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Melatonin
0,25mg/Kg sl before tDCS
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실험적: tDCS
Transcranial direct current stimulation once time.
Dose 2 mA, 20 seconds.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in heat-pain threshold with pain score
기간: Baseline, one week
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Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)
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Baseline, one week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change from baseline Brain-Derived neurotrophic factor (BDNF)
기간: Baseline, one week
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Baseline, one week
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Change from Baseline from Catastrophizing Scale
기간: Baseline, one week
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Baseline, one week
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Change from baseline Inventory of state-trait anxiety Scale
기간: Baseline, one week
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Baseline, one week
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Change from baseline Inventory of Coping
기간: Baseline, one week
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Baseline, one week
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Change from baseline of cortical excitability
기간: Baseline, one week
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Transcranial Magnetic Stimulation (TMS) assessment motor threshold, motor-evoked potentials, silent period, intracortical inhibition and facilitation
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Baseline, one week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wolnei Caumo, Hospital de Clinicas de Porto Alegre - UFRGS
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 (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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