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

May 29, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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 Comparator: 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)
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.
Experimental: 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Time Frame: Baseline, 1 Month, and 3 Months
Spasticity severity was assessed using the Modified Ashworth Scale.
Baseline, 1 Month, and 3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor Recovery Assessed by Brunnstrom Staging
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asya ÖZCAN KAVCI

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Actual)

May 26, 2026

Study Completion (Actual)

May 26, 2026

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBU-FTR-AOK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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