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- Essai clinique NCT06128746
Traitement rTMS de la spasticité chez les enfants atteints de paralysie cérébrale - un ECR
Stimulation magnétique transcrânienne répétitive (rTMS) pour le traitement de la spasticité chez les enfants atteints de paralysie cérébrale hémiplégique - un essai contrôlé randomisé
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Winnie Wan Yee Tso, MBBS
- Numéro de téléphone: +85222554295
- E-mail: wytso@hku.hk
Sauvegarde des contacts de l'étude
- Nom: Chai Yin Charlie Fan, MPhil, OTR
- Numéro de téléphone: +85222554375
- E-mail: charliefan@connect.hku.hk
Lieux d'étude
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 0000
- Recrutement
- Li Ka Shing Faculty of Medicine
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Contact:
- Charlie Fan, MPhil, OTR
- Numéro de téléphone: +85222554375
- E-mail: charliefan@connect.hku.hk
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur factice: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Modified Ashworth Scale
Délai: 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
Délai: 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)
Délai: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gross motor function measure
Délai: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
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
Délai: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
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
|
|
MRI Brain: fMRI and DKI
Délai: Baseline, Day 10, 17 of intervention and 2 months post intervention
|
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
|
|
Purdue Pegboard Test
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies musculaires
- Hypertonie musculaire
- Manifestations neuromusculaires
- Lésions cérébrales chroniques
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Spasticité musculaire
- Paralysie cérébrale
- Thérapeutique
- Thérapie par champ magnétique
- Stimulation magnétique transcrânienne
Autres numéros d'identification d'étude
- rTMSCPHKU
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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