Theta-Burst-Stimulation in Recurrent Stroke Recovery
調査の概要
状態
条件
詳細な説明
To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.
By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.
The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Cologne、ドイツ、50937
- Christian Grefkles
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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
- recurrent stroke
- hemiparesis with impaired hand motor function
Exclusion Criteria:
- Subjects who are legally detained in an official institute (§20 MPG)
- 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
- Frequent 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：基礎科学
- 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：Real-iTBS
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Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
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偽コンパレータ：Sham-iTBS
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Intermittent theta-burst-stimulation (iTBS) protocol
Sham 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 |
|---|---|---|
|
Relative grip force
時間枠：3 months after enrollment
|
grip force as measured with vigorimeter
|
3 months after enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Relative grip force
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Grip force as measured with vigorimeter
|
After 8 days of intervention, and 3 months of enrollment
|
|
Motor function
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Action Research Arm Test, ARAT
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After 8 days of intervention, and 3 months of enrollment
|
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Motor function
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summed |
After 8 days of intervention, and 3 months of enrollment
|
|
Stroke severity
時間枠：After 8 days of intervention, and 3 months of enrollment
|
National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. |
After 8 days of intervention, and 3 months of enrollment
|
|
Degree of disability
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
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After 8 days of intervention, and 3 months of enrollment
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Motor cortex excitability/ Motor evoked potential
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
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After 8 days of intervention, and 3 months of enrollment
|
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Motor cortex excitability/ Resting motor threshold
時間枠：After 8 days of intervention, and 3 months of enrollment
|
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 of enrollment
|
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Motor cortex excitability/ Short-interval intracortical inhibition
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex
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After 8 days of intervention, and 3 months of enrollment
|
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Motor cortex excitability/ Ipsilateral silent period
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition.
Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.
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After 8 days of intervention, and 3 months of enrollment
|
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Quality of life
時間枠：After 8 days of intervention, and 3 months of enrollment
|
EuroQol 5D questionnaire, EQ-5D
|
After 8 days of intervention, and 3 months of enrollment
|
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Activities of daily living at admission and discharge in external rehabilitation facility
時間枠：After 8 days of intervention, and 3 months of enrollment
|
Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL).
A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
The scale yield a score of 0-100.
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After 8 days of intervention, and 3 months of enrollment
|
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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
|
3 months after enrollment
|
協力者と研究者
捜査官
- 主任研究者：Christian Grefkes, MD、University Hospital Cologne
研究記録日
主要日程の研究
研究開始 (実際)
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。
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