Theta-Burst-Stimulation in Early Rehabilitation of Stroke (TheSiReS)
Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten
調査の概要
状態
条件
詳細な説明
To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and occupational therapy. Yet, the majority of patients retain movement impairment relevant for activities of daily living. One explanation for this deficit is the insufficient recovery of connectivity between brain regions after stroke. It is possible to modulate this process by repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex with iTBS enhances the effects of subsequent motor training. The present study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy after sham stimulation. In the first weeks and after three months, motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients.
Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 20/12/2016): Specification of exclusion criteria.
Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 15/11/2018): Change of inclusion and exclusion criteria.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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North Rhine-Westphalia
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Cologne、North Rhine-Westphalia、ドイツ、50924
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln
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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:
- written consent
- age: 40-90 years
- ischemic stroke
- hemiparesis with impaired hand motor function
Exclusion Criteria:
- Subjects who are legally detained in an official institute (§20 MPG)
- Participation in clinical trial within the last 12 weeks
- Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- Medication pump (e.g. insulin pump)
- Metal splinters in eye or head
- Pregnancy / breastfeeding
- Severe Neurodegenerative disease
- Severe Neuroinflammatory disease
- History of seizures / epilepsy
- Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
- Insufficient compliance
- Present or past malignant tumor involving the central nervous system
- Severe Psychiatric disease
- Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis in the hemisphere ipsilateral to the hemiparesis
- Pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae <1cm)
- Known brain lesion (surgical, traumatic)
- Evidence for enhanced cerebral pressure
- Severe cardial dysfunction
- life expectancy < 12 months
- NIHSS Score > 20
- Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl)
- Elevated blood pressure resistant to treatment (RR > 185/110mmHg)
- Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study
- Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
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 |
---|---|
アクティブコンパレータ:Real-rTMS
Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex in the lesioned hemisphere using the intermittent theta-burst-stimulation protocol (iTBS; application of 3 pulses with a frequency of 50 Hz, in a theta-rhythm of 5 Hz for 2 seconds, repeated every 10 seconds, duration of one session: about 3,5 minutes) before physiotherapy for 8 days
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iTBS applied over ipsilesional M1
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偽コンパレータ:Sham-rTMS
Repetitive transcranial magnetic stimulation (rTMS) in sham position (tilted coil over parieto-occipital vertex) before physiotherapy for 8 days
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iTBS applied with tilted coil over parieto-occipital vertex
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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 |
---|---|---|
Relative grip force
時間枠:3 months after enrollment
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grip force as measured with vigorimeter
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3 months after enrollment
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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 |
---|---|---|
Days of rehabilitation after intervention phase
時間枠:3 months after enrollment
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Days of rehabilitation after intervention phase as documented by external rehabilitation facility
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3 months after enrollment
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Relative grip force
時間枠:after 8 days of intervention, and 3 months after enrollment
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grip force as measured with vigorimeter
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after 8 days of intervention, and 3 months after enrollment
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Motor function
時間枠:after 8 days of intervention, and 3 months after enrollment
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Action Research Arm Test, ARAT
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after 8 days of intervention, and 3 months after enrollment
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Motor function
時間枠:after 8 days of intervention, and 3 months after enrollment
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Fugl-Meyer Motor Scale of the upper extremity, FM
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after 8 days of intervention, and 3 months after enrollment
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Stroke severity
時間枠:after 8 days of intervention, and 3 months after enrollment
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National Instituts of Health Stroke Scale, NIHSS
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after 8 days of intervention, and 3 months after enrollment
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Degree of disability
時間枠:after 8 days of intervention, and 3 months after enrollment
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modified Rankin Scale, mRS
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after 8 days of intervention, and 3 months after enrollment
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Motorcortex excitability
時間枠:after 8 days of intervention, and 3 months after enrollment
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Motor evoked potential induced by stimulation of the affected motor cortex, MEP
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after 8 days of intervention, and 3 months after enrollment
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Motorcortex excitability
時間枠:after 8 days of intervention, and 3 months after enrollment
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Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
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after 8 days of intervention, and 3 months after enrollment
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Quality of life
時間枠:after 8 days of intervention, and 3 months after enrollment
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EuroQol 5D questionnaire, EQ-5D
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after 8 days of intervention, and 3 months after enrollment
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Activities of daily living at admission and discharge in external rehabilitation facility
時間枠:3 months after enrollment
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Barthel-Index (BI) scores as documented by external rehabilitation facility
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3 months after enrollment
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Gereon R Fink, Univ.-Prof. Dr.、University of Cologne
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 (実際)
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。