TMS and Botulinum Toxin in Post-Stroke Upper Limb Spasticity
Post-stroke Spasticity of the Upper Limb
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 80 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 39 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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).
¿Quién podría participar?
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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
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)
cTBS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol.
Device: Continuous Theta Burst Stimulation (cTBS)
Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE
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.
Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS) DEVICE
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.
Continuous Theta Burst Stimulation (cTBS) DEVICE
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Plazo: Baseline, 1 Month, and 3 Months
The Modified Ashworth Scale (MAS) measures muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater (worse) spasticity.
Medidas secundarias
Change in Motor Recovery Assessed by Brunnstrom Staging
Plazo: Baseline, 1 Month, and 3 Months
Motor recovery was assessed using the Brunnstrom Staging System. Scores range from Stage 1 (flaccidity) to Stage 6 (near-normal movement), with higher stages indicating better motor recovery.
Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
Plazo: Baseline, 1 Month, and 3 Months
Upper extremity motor function was assessed using the Fugl-Meyer Assessment for Upper Extremity. Scores range from 0 to 66, with higher scores indicating better motor function.
Change in Upper Extremity Use Assessed by Motor Activity Log-28
Plazo: Baseline, 1 Month, and 3 Months
Upper Extremity Use in Daily Activities Assessed by the Motor Activity Log-28. The frequency and quality of upper extremity use in daily activities were assessed using the Motor Activity Log-28. Scores range from 0 to 5 for both the Amount of Use and Quality of Movement scales, with higher scores indicating more frequent use and better quality of movement of the affected upper extremity.
Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
Plazo: Baseline, 1 Month, and 3 Months
Depression was assessed using the Hospital Anxiety and Depression Scale-Depression. Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Ankara Etlik City Hospital, Physical Medicine and Rehabilitation ClinicAnkara, Ankara, Turkey (Türkiye)Estado desconocido
Equipo y fechas
- Patrocinador principal
- Asya ÖZCAN KAVCI
- Inicio del estudio
- 20 ene 2025 Real
- Finalización primaria
- 26 may 2026 Real
- Finalización del estudio
- 26 may 2026 Real
- Primera publicación
- 3 jun 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Comparison of Clinical Outcomes Associated With Different Transcranial Magnetic Stimulation Protocols Combined With Botulinum Toxin-A Injection in Post-Stroke Upper Limb Spasticity
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026