Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC
Effects of Multichannel Transcranial Direct Current Stimulation to Reduce Hypertonia in Patients With Prolonged Disorders of Consciousness: a Pilot Study.
調査の概要
詳細な説明
Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC). A previous study showed that a single stimulation (using transcranial direct current stimulation - tDCS) of the left prefrontal cortex induces an behavioral improvement in some patients in DOC. Nevertheless, patients with DOC suffer from other invalidating dysfunctions such as spasticity (muscle hypertonia). In sroke patients, the inhibition of the motor cortex through cathodes placed over the motor region showed to reduce spasticity.
In this study, investigators aim to assess the effect of single session of transcranial direct current stimulation (tDCS) over right and left fronto-central areas (using 2 anodes and 2 cathodes), on the level of hypertonia and the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3 and F4, and the cathodes over C3 and C4.
tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves motor functions in healthy subjects and patients with stroke or Parkinson's disease.
By reducing the activity of the motor cortex (cathodes) and increasing the activity of the prefrontal cortex (anodes) we expect to observe a better motor function in patients with DOC.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Liege、ベルギー、4000
- University of Liege
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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:
- post comatose patients
- patients in minimally conscious state
- patients with stable condition
- patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)
Exclusion Criteria:
- premorbid neurology antecedent
- patients in coma
- patients < 28 days after the acute brain injury
- patients with a metallic cerebral implant
- cranioplasty
- shunt
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：処理
- 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：active tDCS
Patients will receive tDCS (bilateral fronto-central stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
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tDCS will be applied during 20 minutes with a current of 1 mA preceded and followed by a behavioral assessments (Modified Ashworth Scale and Coma Recovery Scale Revised) and an EEG.
The anodes will be placed over F3 and F4 and the cathodes over C3 and C4.
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偽コンパレータ：sham tDCS
Patients will receive sham tDCS (5 seconds of stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
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Indentical to the active tDCS, except that the stimulation is terminated after 5 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 |
|---|---|---|
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Change in MAS scores
時間枠：baseline and directly after tDCS (20 minutes)
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Modified Ashworth Scale (MAS) will by assessed before and after tDCS (active and sham).
Comparison of treatment effect (MAS score after tDCS minus before) between active and sham tDCS.
The MAS is a 5 points scale going from 0 (no spasticity) and 5 (extreme spasticity).
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baseline and directly after tDCS (20 minutes)
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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 |
|---|---|---|
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Change in the CRS-R total score
時間枠：Baseline and directly after the tDCS (20 minutes)]
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Coma Recovery Scale Revised (CRS-R) will be performed before and after tDCS (anodal and sham).
Comparison of the treatment effect (CRS-R total score score after tDCS minus before) between real and sham tDCS.
The CRS-R is 23 points scale with 6 sub-scales (lower scores refer to reflexes, while higher scores refer to more complex behaviors).
The total score is the sum of the scores in the 6 sub-scales.
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Baseline and directly after the tDCS (20 minutes)]
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Change in brain oscillations
時間枠：Baseline and directly after the tDCS (20 minutes)
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8 channels electroencephalography (EEG) will be record before and after tDCS to record potential cortical changes induce by the stimulation.
EEG power will be compared in different bandwidths (delta, theta, alpha, beta).
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Baseline and directly after the tDCS (20 minutes)
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2014/280B
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