脳性麻痺の小児における痙縮の rTMS 治療 - RCT
片麻痺性脳性麻痺児の痙縮治療のための反復経頭蓋磁気刺激 (rTMS) - ランダム化比較試験
This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training.
Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.
調査の概要
状態
条件
詳細な説明
Cerebral palsy is the most common cause of lifelong physical disability in childhood, with an estimated prevalence of 1.5 per 1000 living biths for primary school-aged children. Spasticity is the most common symptoms in children with cerebral palsy, leading to muscle weakness affecting gross motor functions and causing complications such as pain, contracture and subluzation which will lead to inability to perform activity-based training and subsequently lead to further muscle weakness. Standard therapy with regular physiotherapy and occupational therapy are essential but time-consuming and the effects might not last for longer duration. Patients or caregivers decline medications because of side effects drowsiness while other interventions such as intra-thecal baclofen pump, rhizotomy or surgery are invasive.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has the ability to modulate excitation of the motor cortex area of the brain. There were past studies suggesting that using contralesional inhibitory rTMS was safe and feasible for patients with paediatric subcortical stroke and seemed to improve hand function in patients with hemiparesis. However, limited studies have been published on the effects of rTMS on improving spasticity in children with cerebral palsy. Hence, the objective of this study is to use low-frequency rTMS to the contra-lesional hemisphere in children with hemiplegic cerebral palsy to investigate if rTMS follow by intensive limb training would improve spasiticity of these children and whether the improvement can be sustained for a longer time. The underlying mechanisms that lead to the changes clinically will also be investigated by TMS and MRI.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Winnie Wan Yee Tso, MBBS
- 電話番号:+85222554295
- メール:wytso@hku.hk
研究連絡先のバックアップ
- 名前:Chai Yin Charlie Fan, MPhil, OTR
- 電話番号:+85222554375
- メール:charliefan@connect.hku.hk
研究場所
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Hong Kong
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Hong Kong、Hong Kong、香港、0000
- 募集
- Li Ka Shing Faculty of Medicine
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コンタクト:
- Charlie Fan, MPhil, OTR
- 電話番号:+85222554375
- メール:charliefan@connect.hku.hk
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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:
- Patients aged between 4 years and 18 years
- Diagnosis of hemiplegia
- Upper limb spasticity ≥ 1
- IQ ≥ 50
Exclusion Criteria:
- Any contra-indications to rTMS
- Severe spasticity (score of 4 or more in Ashworth scale)
- Uncontrollable epilepsy
- History of Botulinum toxin A injection in previous 6 months
- Upper limb casting in previous 6 months
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:Interventional rTMS group
The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 1.5 hours of motor training. |
1 Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training. |
|
偽コンパレータ:Sham rTMS group
The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 1.5 hours of motor training. |
Sham Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training. |
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 |
|---|---|---|
|
Modified Ashworth Scale
時間枠:Baseline, Day 10, 17 of intervention and 2 months post intervention
|
Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
|
The range of motion scores
時間枠:Baseline, Day 10, 17 of intervention and 2 months post intervention
|
ROM of thumb adduction, wrist dorsal flexion and extension, and elbow dorsal flexion and extension. Patients' range of motion score will be compared to the normative values |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
|
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
時間枠:Baseline, Day 10, 17 of intervention and 2 months post intervention
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The BOT-2 provides a comprehensive overview of fine and gross motor skills in children and young adults within school age-range. |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gross motor function measure
時間枠:Baseline, Day 10, 17 of intervention and 2 months post intervention
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Changes in motor function. A 4-point Likert scale with higher score indicates better motor function |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
|
Pediatric Quality of Life Cerebral Palsy module
時間枠:Baseline, Day 10, 17 of intervention and 2 months post intervention
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Quality of life measurement. Scores range from 0 to 100 with higher score indicate better quality of life. |
Baseline, Day 10, 17 of intervention and 2 months post intervention
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MRI Brain: fMRI and DKI
時間枠:Baseline, Day 10, 17 of intervention and 2 months post intervention
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Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
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Purdue Pegboard Test
時間枠:Baseline, Day 10, 17 of intervention and 2 months post intervention
|
A standardized evaluation tool used to measure gross movements of hands, fingers, and arms, as well as fine fingertip dexterity. |
Baseline, Day 10, 17 of intervention and 2 months post intervention
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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