Transcranial Electrical Stimulation With Special Waveform for Upper Extremity Rehabilitation for Patients With Stroke
2021年4月12日 更新者：Taipei Medical University
Transcranial electrical stimulation (tCES) is contemporarily important issues in the advanced rehabilitation medicine.
tCES can selectively change the excitability of regional cortex with non-invansive and safety properties.
Therefore, the investigators aim to develop a set of tCES system with special waveforms for using in clinical rehabilitation of upper extremities.
This developed tCES system is smaller than all commercial available products, which could be conveniently and portably wore on head for clinical rehabilitation.
In addition, the present tCES system with special waveforms developing by the investigators is much more efficient on improving neuroplasticity than the traditional transcranial direct current stimulation (tDCS) in rats.
The investigators hope the tCES system combined with the rehabilitation of body extremities will become a routine treatment for stroke patients at hospitals or residential rehabilitation in the future.
調査の概要
詳細な説明
Transcranial direct current stimulation (tDCS) and intermittent theta burst stimulation (iTBS) were both demonstrated to have therapeutic potentials to rapidly induce neuroplastic effects in various rehabilitation training regimens. Recently, the investigators have developed a novel transcranial electrostimulation device that can flexibly output an electrical current with combined tDCS and iTBS waveforms. However, limited studies have determined the therapeutic effects of this special waveform combination on clinical rehabilitation. Herein, the investigators aiming to brain stimulation effects of tDCS-iTBS on upper-limb motor function in chronic stroke patients.
Twenty-four subjects with a chronic stroke were randomly assigned to a real non-invasive brain stimulation (NIBS; subjects received the real tDCS+iTBS output) group or a sham NIBS (subjects received sham tDCS+iTBS output) group. All subjects underwent 1 h treatment of a conventional rehabilitation program (3 days a week for 6 weeks), where a 20-min NIBS intervention was simultaneously applied during conventional rehabilitation. Outcome measures were assessed before and immediately after the intervention period: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Jebsen-Taylor Hand Function Test (JTT), and Finger-to-Nose Test (FNT).
研究の種類
介入
入学 (実際)
24
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Taipei city、台湾
- Taipei Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age ≥ 20 years.
- Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- 6 months to 5 years after stroke.
- Adequate understanding of verbal/written information and physically able to complete the motor learning of functional tasks with the affected hand.
Exclusion Criteria:
- Extremely sensitive to electrical stimulation and cannot tolerate it.
- Contracture on upper extremities, and limitation in joint range of motion.
- The muscle tone was severe spasticity.
- Ossification or inflammation in muscle tissue.
- A history of cardiopulmonary disease or arrhythmia.
- With implantable medical electronic devices, like pacemaker.
- Pressure sores or wounds on the skin of head and upper extremities.
- Metal implants in the head (neck).
- Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
- A history of seizure or other brain pathology.
- Brain surgery or severe brain trauma.
- Drug or alcohol abuse.
- Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
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実験的：tCES & upper extremity rehabilitation
The experiment group will receive tCES combined with upper extremity rehabilitation of affected side.
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The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms.
tCES will be applied for 20 minutes at an intensity of 1.0 -1.5 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 6 weeks.
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偽コンパレータ：Sham tCES & upper extremity rehabilitation
The sham control group will receive sham tCES combined with upper extremity rehabilitation of affected side.
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The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms.
Sham tCES will consist of a 5-second ramp up to 1.0-1.5 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 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 from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
時間枠：Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The FMA-UE was performed (score ranges from 0 to 66) to assess upper limb motor recovery.
Each movement is estimated by a 3-point scale (0-1-2).
The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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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 from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention
時間枠：Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The JTT assesses hand functions commonly used in activities of daily living.
The subtests are scored according to time taken to complete the task.
Total score is the sum of time taken for each subtest, with shorter times indicating better performance.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Change from baseline in the Finger to Nose Test after intervention
時間枠：Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The Finger to Nose Test assesses coordination of upper-extremity movement.
The number of complete nose-target movements during a 1 min period will be recorded.
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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Modified Ashworth scale (MAS) measures
時間枠：Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity
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Baseline (within 7 days ahead to the 1st intervention session) and after 6-week intervention (within 7 days after the last intervention session)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Chi-Wei Peng, Ph.D.、School of Biomedical Engineering, Taipei Medical University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年3月2日
一次修了 (実際)
2020年1月31日
研究の完了 (実際)
2020年4月30日
試験登録日
最初に提出
2020年4月27日
QC基準を満たした最初の提出物
2020年4月27日
最初の投稿 (実際)
2020年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月15日
QC基準を満たした最後の更新が送信されました
2021年4月12日
最終確認日
2020年4月1日
詳しくは
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