A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.
The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.
Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.
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
研究連絡先
- 名前：Hongjie Jiang, Dr.
- 電話番号：+86 13777830137
- メール：insjhj@zju.edu.cn
研究場所
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Chongqing、中国、400000
- 募集
- Southwest Hospital
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コンタクト：
- Jingming Hou, Dr.
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Zhejiang
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Hangzhou、Zhejiang、中国、310014
- 募集
- Zhejiang Provincial People's Hospital
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コンタクト：
- Ruidong Cheng, Dr.
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Hangzhou、Zhejiang、中国、310009
- 募集
- SAHZhejiangU
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コンタクト：
- Hongjie Jiang, Dr.
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Hangzhou、Zhejiang、中国、310000
- 募集
- Rainbowfish Rehabilitation Nursing Care
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コンタクト：
- Ran Wang, Dr.
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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:
- 18-60 year-old
- diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
- cognitive function, perceptual function decline after stroke
- first onset and duration of 3-12 months
- right-handed
- MMSE ≤25
- MoCA ≤25
- sign informed consent voluntarily and comply with the study plan
Exclusion Criteria:
- NIHSS ≥21 points
- MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
- taking drugs that affect central nervous activity, such as nerve antagonists
- specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
- patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
- patients with a previous history of epilepsy, mental illness or skull injury
- patients with dementia or obvious cognitive dysfunction before stroke
- patients with aphasia or dysarthria and cannot complete the scale evaluation
- pregnancy
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：multi-channel tDCS
In the multi-channel tDCS stimulation group, a 1:4 (anode: cathode) approach was applied, with the central anode placed in the left dorsolateral prefrontal cortex (dlPFC) (reference 10-20 standard lead EEG), and the remaining cathode distributed around the central electrode. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
multi-channel transcranial direct current stimulation, tDCS
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|
実験的：single-channel tDCS
The anode electrode of the single-channel tDCS stimulation group was placed in the left dlPFC, and the cathode electrode was placed in the right orbital forehead. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
single-channel transcranial direct current stimulation
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偽コンパレータ：sham stimulation
The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
|
multi-channel transcranial direct current stimulation, tDCS
single-channel transcranial direct current stimulation
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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 |
|---|---|---|
|
MMSE
時間枠：Change from Baseline MMSE at 2 weeks and 3 months after intervention
|
Mini-mental State Examination
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Change from Baseline MMSE at 2 weeks and 3 months after intervention
|
|
MoCA
時間枠：Change from Baseline MoCA at 2 weeks and 3 months after intervention
|
Montreal Cognitive Assessment
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Change from Baseline MoCA at 2 weeks and 3 months after intervention
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AVLT
時間枠：Change from Baseline AVLT at 2 weeks and 3 months after intervention
|
The Auditory-Verbal Learning Test
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Change from Baseline AVLT at 2 weeks and 3 months after intervention
|
|
WAIS-DST
時間枠：Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
|
WAIS Digit Symbol Test
|
Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
DEX
時間枠：Change from Baseline DEX at 2 weeks and 3 months after intervention
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Dysexecutive Ques-tionnaire
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Change from Baseline DEX at 2 weeks and 3 months after intervention
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GNAT
時間枠：Change from Baseline GNAT at 2 weeks and 3 months after intervention
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Go/No-go Association Task
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Change from Baseline GNAT at 2 weeks and 3 months after intervention
|
協力者と研究者
捜査官
- スタディチェア：Hongjie Jiang, Dr.、Second Affiliated Hospital, School of Medicine, Zhejiang University
- 主任研究者：Ruidong Cheng, Dr.、Zhejiang Provincial People's Hospital
- 主任研究者：Rang Wang, Dr.、Rainbowfish Rehabilitation Nursing Care
- 主任研究者：Jingming Hou, Dr.、Southwest Hospital, China
研究記録日
主要日程の研究
研究開始 (予想される)
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 (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。