Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients
Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.
Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.
Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Zuid-Holland
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Rotterdam、Zuid-Holland、オランダ、3015LJ
- 募集
- Rijndam
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コンタクト:
- Gerard Ribbers, PhD MD
- 電話番号:+31102412411
- メール:gribbers@rijndam.nl
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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:
- Subacute stroke (within 1-4 weeks post stroke)
- Acute hemiparesis (Fugl-Meyer Stage < IV) with single thromboembolic non-hemorrhagic infarction documented by a neurologist
- Aged 18-79
Exclusion Criteria:
- Absence of voluntary movement (Fugl-Meyer Stage < III)
- Head injury or the presence of intracranial metal or intracranial lesions
- History of cranial irradiation
- History of epilepsy
- Presence of a pacemaker
- Taking anticonvulsant or neuroleptic medication
- Substance abuse
- Inability to understand instructions
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:並列代入
- 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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プラセボコンパレーター:Sham
Motor training of the affected upper extremity combined with sham tDCS.
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Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
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実験的:tDCS
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
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Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
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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 |
時間枠 |
---|---|
Change from baseline in Upper Extremity Fugl Meyer Assessment
時間枠:Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
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Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
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二次結果の測定
結果測定 |
時間枠 |
---|---|
ARAT
時間枠:Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
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Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
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Hand grip strength
時間枠:Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
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Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
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10-meter walk test
時間枠:Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
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Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
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EuroQol-5D
時間枠:12 weeks
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12 weeks
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Barthel Index
時間枠:Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
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Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
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HADS
時間枠:Baseline; 4 weeks and 12 weeks
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Baseline; 4 weeks and 12 weeks
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MoCA
時間枠:Baseline; 4 weeks and 12 weeks
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Baseline; 4 weeks and 12 weeks
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Wong-Baker FACES Pain Rating Scale
時間枠:Every stimulation session
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Every stimulation session
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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
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 (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
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。
tDCSの臨床試験
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了
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Shirley Ryan AbilityLabNational Institute on Disability, Independent Living, and Rehabilitation Research募集
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University of California, Los AngelesNational Institute of Mental Health (NIMH)完了
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Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)わからない