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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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RS
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Porto Alegre、RS、ブラジル、900035-903
- 募集
- Hospital de Clinicas de Porto Alegre
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コンタクト：
- Wolnei Caumo
- 電話番号：555133590083
- メール：caumo@cpovo.net
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副調査官：
- Nadia Jardim, MD, Msc
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Melatonin
0,25mg/Kg sl before tDCS
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|
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実験的：tDCS
Transcranial direct current stimulation once time.
Dose 2 mA, 20 seconds.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in heat-pain threshold with pain score
時間枠：Baseline, one week
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Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)
|
Baseline, one week
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline Brain-Derived neurotrophic factor (BDNF)
時間枠：Baseline, one week
|
Baseline, one week
|
|
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Change from Baseline from Catastrophizing Scale
時間枠：Baseline, one week
|
Baseline, one week
|
|
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Change from baseline Inventory of state-trait anxiety Scale
時間枠：Baseline, one week
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Baseline, one week
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Change from baseline Inventory of Coping
時間枠：Baseline, one week
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Baseline, one week
|
|
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Change from baseline of cortical excitability
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Wolnei Caumo、Hospital de Clinicas de Porto Alegre - UFRGS
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。