RecruitingNot ApplicableNCT05646134

Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Motor Function in Stroke Patients


Sponsor

Lithuanian University of Health Sciences

Enrollment

150 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it seeks to answer are: 1. Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients. 2. Which stimulation protocol (low frequency - LF or high-frequency - HF) has better outcomes for improving upper extremity motor function in stroke patients? Participants will receive 10 procedures of repetitive transcranial magnetic stimulation (rTMS) over two weeks. They will be randomly assigned into low-frequency, high-frequency rTMS groups or sham stimulation groups. Upper extremity motor function will be evaluated twice: before stimulation and 3-4 weeks after stimulation. Researchers will compare sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Ischemic stroke of the middle cerebral artery, confirmed by instrumental tests (CT, MRI).
  • Acute hemiplegia/hemiparesis, hand motor deficit, muscle strength ≤ 4 points (as assessed by the Lovett scale).
  • Time after the stroke before inclusion in the study is no more than 1 month.
  • No severe deficit in cognitive functions.

Exclusion Criteria7

  • Patients with implanted ferromagnetic or other metal devices sensitive to a magnetic field in the head or neck area; cochlear implants; implanted neurostimulators, pacemakers, or drug delivery pumps.
  • Complete aphasia or severe cognitive impairment.
  • Taking tricyclic antidepressants, neuroleptics, or benzodiazepines.
  • Previous skull fractures or other head injuries with loss of consciousness.
  • History of epilepsy or seizures.
  • Spasticity of the upper limb (Ashworth scale >2 b.).
  • Pregnancy

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation

Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability.

DEVICESham Transcranial Magnetic Stimulation

During Sham Transcranial Magnetic Stimulation the coil will be facing the wall making the stimulation inactive


Locations(1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

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NCT05646134


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