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TMS AND BOTULINUM TOXIN IN POST-STROKE UPPER LIMB SPASTICITY (TMS)

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Tyrkiet (Türkiye)
    • Ankara
      • Ankara, Ankara, Tyrkiet (Türkiye), 06010
        • Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic

Deltagelseskriterier

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Berettigelseskriterier

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Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol.
Enhed: Repetitive Transcranial Magnetic Stimulation (rTMS)
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-komparator: 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.
Enhed: Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)
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.
Eksperimentel: cTBS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol.
Enhed: Continuous Theta Burst Stimulation (cTBS)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Tidsramme: Baseline, 1 Month, and 3 Months
Spasticity severity was assessed using the Modified Ashworth Scale.
Baseline, 1 Month, and 3 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Motor Recovery Assessed by Brunnstrom Staging
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Baseline, 1 Month, and 3 Months
Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Asya ÖZCAN KAVCI

Efterforskere

  • Ledende efterforsker: Damla CANKURTARAN, Associate Professor, MD, Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. januar 2025

Primær færdiggørelse (Faktiske)

26. maj 2026

Studieafslutning (Faktiske)

26. maj 2026

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SBU-FTR-AOK-01

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

Individual participant data will not be shared due to privacy and confidentiality considerations.

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