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

Lithuanian University of Health Sciences

Status: Enrolling

Conditions: Stroke, Ischemic

Treatments: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05646134

rTMS_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (as assessed 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 criteria

1. 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.
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Low Frequency Experimental Group

Experimental group

Description:

Participants in this Arm will receive 10 sessions of Low Frequency (1 Hz) rTMS Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

High Frequency Experimental Group

Experimental group

Description:

Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham Stimulation Control Group

Sham Comparator group

Description:

Participants in this Arm will receive 10 sessions of Sham rTMS

Treatment:

Device: Sham Transcranial Magnetic Stimulation