Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke (NEUROSTIM)
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
調査の概要
詳細な説明
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Sao Paulo、ブラジル、05652-901
- Danielle Boasquevisque
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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:
- Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- Unilateral paresis of upper limb
- National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- Ability to provide written informed consent (patient ou legal representative).
Exclusion Criteria:
- Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- Neurologic diseases except migraine.
- Modified Rankin Scale > 2 prior to stroke.
- Advanced systemic disease such as cancer or advanced chronic renal disease.
- Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
- Contraindication for physical therapy.
- Pregnancy.
- Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
- Comprehension aphasia
- Dementia
- Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
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：トリプル
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+ Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes.
After active session of tDCS, the patient will receive physical therapy for 60 minutes.
Number of treatment sessions: 6 (3 times a week, for 2 weeks)
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Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 60 minutes
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偽コンパレータ：Sham tDCS+Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
In sham tDCS, no current will be delivered through the tDCS device.
Physical therapy will be administered for 60 minutes
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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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Safety of the intervention as assessed by frequency of adverse events
時間枠：2 weeks
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frequency of adverse events in the active and sham arms
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2 weeks
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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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Improvement post treatment as measured by the Modified Rankin Scale
時間枠：2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the NIH Stroke Scale
時間枠：2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Stroke Impact Scale
時間枠：2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
時間枠：2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Modified Ashworth Scale
時間枠：2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Motor Activity Log
時間枠：2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Montreal Cognitive Assessment Test
時間枠：2 weeks and 14 weeks
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No cognitive deterioration post treatment
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2 weeks and 14 weeks
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Structural Connectivity as measured by diffusion tensor imaging analysis
時間枠：2 weeks
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Improvement post treatment
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2 weeks
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Functional Connectivity as measured by resting-state functional magnetic imaging analysis
時間枠：2 weeks
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Improvement post treatment
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2 weeks
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Improvement post treatment as measured by the Barthel index
時間枠：2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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Safety of the intervention as assessed by frequency of adverse events
時間枠：14 weeks
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frequency of adverse events in the active and sham arms
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14 weeks
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Improvement post treatment as measured by Pittsburgh Sleep Quality Index
時間枠：2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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協力者と研究者
捜査官
- 主任研究者：Adriana B Conforto, MD Phd、Hospital Israelita Albert Einstein
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 (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 (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。
Sham tDCSの臨床試験
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The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of Waterloo募集
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Spaulding Rehabilitation HospitalNational Institute of Neurological Disorders and Stroke (NINDS); Highland Instruments, Inc.積極的、募集していない
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I.R.C.C.S. Fondazione Santa LuciaCampus Bio-Medico University完了
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Pusan National University Yangsan Hospital積極的、募集していない
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Universitätsklinikum Hamburg-Eppendorf完了
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National Rehabilitation Center, Seoul, Koreaわからない
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Nanyang Technological UniversityMinistry of Education, Singapore; National Institute of Education, Singaporeまだ募集していませんエージング | エグゼクティブ機能 | 経頭蓋直流刺激 (tDCS) | 経頭蓋電気刺激