Structural Mechanisms of Dual-Target tDCS in Stroke Hemiparetic Hand
Multimodal MRI-Based Study of the Structural Mechanisms Underlying Interhemispheric Network Reorganization Induced by Dual-Target tDCS in Stroke Hemiparetic Hand
This is a single-center, randomized, single-blind study investigating the effects of dual-target transcranial direct current stimulation (tDCS) combined with task-oriented functional electrical stimulation on upper limb recovery in patients with non-acute post-stroke hemiplegia. A total of 56 participants will be recruited and randomly assigned (1:1) to the dual M1 tDCS group or sham stimulation group. The intervention is delivered five times per week for four weeks, with 20 sessions in total. Multimodal MRI (T1W, T2W, and DTI) will be used to assess structural and network-level reorganization of sensorimotor pathways, including the corticospinal tract, in response to tDCS.
The primary outcome is the Broetz hand function score, evaluated at baseline, post-intervention, and six-month follow-up. Secondary outcomes include Fugl-Meyer Assessment of the upper extremity (FMA-UE) and multimodal MRI-derived measures of white matter integrity. This study aims to elucidate the structural constraints underlying sensorimotor network lateralization and to identify responder and non-responder profiles based on corticospinal tract damage, providing mechanistic insight into individualized tDCS-based neurorehabilitation after stroke.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Diagnosed with stroke according to the "Diagnostic Criteria for Major Cerebrovascular Diseases in China, 2019", confirmed by cranial CT or MRI.
- First-ever unilateral subcortical stroke (involving the corona radiata, basal ganglia, thalamus, internal capsule, etc.).
- Age 30-75 years.
- Right-handed prior to stroke onset.
- Stroke onset ≥ 2 weeks.
- Hemiplegic hand function at Brunnstrom Stage I-III.
- Written informed consent provided by the patient or legally authorized representative.
Exclusion Criteria:
- Any contraindications to MRI.
- History of other neurological disorders or substance abuse.
- Unstable conditions or rapidly progressive/malignant diseases, e.g., severe atrial fibrillation.
- Severe skin allergies.
- Inability to cooperate with basic communication or assessments, such as severe aphasia.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Active Dual M1 tDCS
|
Bilateral M1 high-definition transcranial direct current stimulation (HD-tDCS) at 2 mA for 20 minutes per session, delivered five times per week for 4 weeks (total 20 sessions).
Electrodes are placed over the left and right primary motor cortices.
Each session is combined with task-oriented hand rehabilitation exercises targeting the affected upper limb.
This intervention is designed to modulate interhemispheric sensorimotor network reorganization and promote hand function recovery after stroke.
|
|
偽コンパレータ：Sham Dual M1 tDCS
|
Bilateral M1 sham HD-tDCS: electrodes placed identically to the active group, with current ramped up and down for 10 seconds at the start and end of each 20-minute session, without sustained stimulation.
Sessions are also combined with task-oriented hand rehabilitation exercises.
This sham intervention serves as a control to evaluate the efficacy of active tDCS on interhemispheric network reorganization and hand function recovery.
|
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 |
|---|---|
|
Broetz Hand Function Score
時間枠：Baseline (T0), post-intervention (T1, after 4 weeks), 6-month follow-up (T2)
|
Baseline (T0), post-intervention (T1, after 4 weeks), 6-month follow-up (T2)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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。