TMS AND BOTULINUM TOXIN IN POST-STROKE UPPER LIMB SPASTICITY (TMS)
29 mai 2026 mis à jour par: Asya ÖZCAN KAVCI
COMPARISON OF CLINICAL OUTCOMES ASSOCIATED WITH DIFFERENT TRANSCRANIAL MAGNETIC STIMULATION PROTOCOLS COMBINED WITH BOTULINUM TOXIN-A INJECTION IN POST-STROKE UPPER LIMB SPASTICITY
Post-stroke upper limb spasticity is an important condition that negatively affects motor recovery, upper limb functions, and activities of daily living.
Multimodal treatment approaches are recommended in the management of spasticity.
In recent years, the effects of transcranial magnetic stimulation (TMS) on upper limb functions and spasticity have been investigated.
However, the clinical effects of different TMS protocols combined with botulinum toxin-A (BTX-A) treatment and which protocol may be more effective remain unclear.
The aim of this observational study is to compare the clinical effects of different TMS protocols in patients with post-stroke upper limb spasticity receiving BTX-A treatment and to evaluate the most appropriate TMS protocol.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
As part of the study, patients who received botulinum toxin type A (BTX-A) injections for upper extremity spasticity following stroke were evaluated using different TMS protocols.
All patients received a standard conventional physical therapy program.
TMS sessions were conducted using an inhibitory protocol, with a total of 10 sessions administered to the contralateral hemisphere at least 3 days per week.
Clinical evaluations were performed at baseline, at 1 month, and at 3 months.
Thus, the early and long-term clinical outcomes of treatment were investigated.
Spasticity was assessed using the Modified Ashworth Scale (MAS), motor improvement using the Brunnstrom staging system, upper extremity motor function using the Fugl-Meyer Assessment, and upper extremity use in activities of daily living using the Motor Activity Log-28 (MAL-28).
Additionally, patients' anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS).
Type d'étude
Interventionnel
Inscription (Réel)
39
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Ankara
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Ankara, Ankara, Turquie (Türkiye), 06010
- Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Diagnosis of stroke (ischemic or hemorrhagic)
- Time since stroke onset between 3 and 24 months
- Age between 18 and 80 years
- Upper extremity motor recovery at Brunnstrom Stages 3-5
- Spasticity in the elbow, wrist, or finger flexor muscle groups of the upper extremity with a Modified Ashworth Scale (MAS) score between +1 and 3
- Receipt of botulinum toxin-A injection to the affected upper extremity within the previous week
Exclusion Criteria:
- History of epileptic seizures, epileptiform EEG findings, increased seizure risk, or use of antiepileptic medication
- Presence of implanted metallic or electronic devices (e.g., cardiac pacemaker, intrathecal baclofen pump)
- Pregnancy or lactation
- Presence of neurological disorders other than stroke
- History of cranial surgery
- Orthopedic conditions or previous orthopedic surgery limiting upper extremity movement
- Severe upper extremity spasticity (MAS >3) or presence of contracture
- Uncontrolled hypertension, advanced heart failure (NYHA Class III-IV), chronic obstructive pulmonary disease (COPD), active infection, severe hepatic failure, or severe renal failure
- History of malignancy
- Severe cognitive impairment (Mini-Mental State Examination score <24)
- Severe aphasia or communication disorder that would interfere with participation in the study
- Botulinum toxin injection administered to the upper extremity in a separate treatment session within the previous 3 months
- Any change in medication type or dosage within the previous month for oral medications used in the management of spasticity
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol.
|
Repetitive transcranial magnetic stimulation (rTMS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol.
Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
|
|
Comparateur factice: Sham rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and sham repetitive transcranial magnetic stimulation (sham rTMS).
The sham procedure was designed to mimic active stimulation without delivering therapeutic stimulation.
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Sham repetitive transcranial magnetic stimulation (sham rTMS) was administered using procedures designed to mimic active stimulation without delivering therapeutic magnetic stimulation.
Treatment was provided in combination with botulinum toxin-A injections and conventional physical therapy.
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Expérimental: cTBS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol.
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Continuous theta burst stimulation (cTBS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol.
Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Délai: Baseline, 1 Month, and 3 Months
|
Spasticity severity was assessed using the Modified Ashworth Scale.
|
Baseline, 1 Month, and 3 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Motor Recovery Assessed by Brunnstrom Staging
Délai: Baseline, 1 Month, and 3 Months
|
Motor recovery of the upper extremity and hand was assessed using Brunnstrom staging.
|
Baseline, 1 Month, and 3 Months
|
|
Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
Délai: Baseline, 1 Month, and 3 Months
|
Upper extremity motor function was assessed using the Fugl-Meyer Assessment.
|
Baseline, 1 Month, and 3 Months
|
|
Change in Upper Extremity Use Assessed by Motor Activity Log-28
Délai: Baseline, 1 Month, and 3 Months
|
The frequency and quality of upper extremity use in daily activities were assessed using the Motor Activity Log-28.
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Baseline, 1 Month, and 3 Months
|
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Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
Délai: Baseline, 1 Month, and 3 Months
|
Anxiety and depression levels were assessed using the Hospital Anxiety and Depression Scale.
|
Baseline, 1 Month, and 3 Months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Damla CANKURTARAN, Associate Professor, MD, Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 janvier 2025
Achèvement primaire (Réel)
26 mai 2026
Achèvement de l'étude (Réel)
26 mai 2026
Dates d'inscription aux études
Première soumission
29 mai 2026
Première soumission répondant aux critères de contrôle qualité
29 mai 2026
Première publication (Réel)
3 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SBU-FTR-AOK-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared due to privacy and confidentiality considerations.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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