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

Last updated: December 2, 2022
Sponsor: Lithuanian University of Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Blood Clots

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05646134
rTMS_1
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 150
Study Start date:
June 01, 2021
Estimated Completion Date:
June 01, 2026

Study Description

The aim of this clinical trial is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on upper extremity motor function in stroke patients. The main questions it aims 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 by conducting Fugl Meyer Assessment for Upper Extremity, Box and Blog test, nine-hole peg test, and by measuring hand grip strength.

Researchers will compare experimental groups with sham stimulation to see if it has the same or better outcomes for improving upper extremity motor function in stroke patients than real rTMS.

Connect with a study center

  • Lithuanian University of Health Sciences

    Kaunas, 44307
    Lithuania

    Active - Recruiting

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