CompletedNot Applicable

TMS AND BOTULINUM TOXIN IN POST-STROKE UPPER LIMB SPASTICITY

Turkey (Türkiye)39 participantsStarted 2025-01-20

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 medicati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Spasticity Assessed by Modified Ashworth Scale (MAS)

Timeframe: Baseline, 1 Month, and 3 Months

Trial details

NCT IDNCT07624149

SponsorAsya ÖZCAN KAVCI

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-05-26

View on ClinicalTrials.gov More Post-stroke Spasticity of the Upper Limb trials