TMS AND BOTULINUM TOXIN IN POST-STROKE UPPER LIMB SPASTICITY (TMS)
29 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
39
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ankara
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Ankara, Ankara, Turkije (Türkiye), 06010
- Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol.
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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.
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Sham-vergelijker: 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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Experimenteel: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Tijdsspanne: Baseline, 1 Month, and 3 Months
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Spasticity severity was assessed using the Modified Ashworth Scale.
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Baseline, 1 Month, and 3 Months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Motor Recovery Assessed by Brunnstrom Staging
Tijdsspanne: Baseline, 1 Month, and 3 Months
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Motor recovery of the upper extremity and hand was assessed using Brunnstrom staging.
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Baseline, 1 Month, and 3 Months
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Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
Tijdsspanne: Baseline, 1 Month, and 3 Months
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Upper extremity motor function was assessed using the Fugl-Meyer Assessment.
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Baseline, 1 Month, and 3 Months
|
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Change in Upper Extremity Use Assessed by Motor Activity Log-28
Tijdsspanne: Baseline, 1 Month, and 3 Months
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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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Damla CANKURTARAN, Associate Professor, MD, Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
20 januari 2025
Primaire voltooiing (Werkelijk)
26 mei 2026
Studie voltooiing (Werkelijk)
26 mei 2026
Studieregistratiedata
Eerst ingediend
29 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 mei 2026
Eerst geplaatst (Werkelijk)
3 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
29 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SBU-FTR-AOK-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be shared due to privacy and confidentiality considerations.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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