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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Petrusevičienė, MD; Phone Number: +37064410732; Email: lciginskaite@gmail.com
• Study Contact Backup: Name: Raimondas Savickas, Professor; Phone Number: +37068619797; Email: raimondas.savickas@lsmuni.lt

Study Locations

• Lithuania
  • Kaunas, Lithuania, 44307
    • Recruiting
    • Lithuanian University of Health Sciences
    • Contact: Judita Tuzaitė; Phone Number: +370 32 72 01; Email: rektoratas@lsmuni.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Frequency Experimental Group; 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	Device: Repetitive Transcranial Magnetic Stimulation; Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability.
Experimental: High Frequency Experimental Group; Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS	Device: Repetitive Transcranial Magnetic Stimulation; Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability.
Sham Comparator: Sham Stimulation Control Group; Participants in this Arm will receive 10 sessions of Sham rTMS	Device: Sham Transcranial Magnetic Stimulation; During Sham Transcranial Magnetic Stimulation the coil will be facing the wall making the stimulation inactive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of upper limb motor score in Fugl-Meyer Assessment	Fugl-Meyer test for Upper Extremity will be performed before and one month after 10 rTMS sessions. The minimum value of the Fugl-Meyer Assessment is 0 whereas the maximum value is 66 points. The higher the score the better the motor function of the upper extremity.	7 weeks
Change of Nine Hole Peg Test (9HPT) score	Nine Hole Peg Test (9HPT) will be performed before and one month after 10 rTMS sessions for measuring finger dexterity. During 9HPT a patient takes the pegs from a container, one by one, and places them into the holes on the board, as quickly as possible, using only the hand. The faster a patient finishes the test the better finger dexterity (measured by seconds).	7 weeks
Change of box and block test (BBT) score	Box and block test (BBT) will be performed before and one month after 10 rTMS sessions for measuring unilateral gross manual dexterity. During BBT a patient moves, one by one, the maximum number of blocks from one compartment of a box to another within 60 seconds. The more blocks are moved to another compartment the better the manual dexterity of the upper extremity.	7 weeks
Change of hand grip strength	Hand grip strength will be measured in kilograms using a dynamometer before and one month after 10 rTMS sessions. The higher the score the stronger the forearm muscles.	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Functional Independence Measure (FIM) test score.	Functional Independence Measure (FIM) will be performed before and one month after 10 rTMS sessions. The minimum value of FIM is 18 whereas the maximum value is 126. The higher the score the better functional independence.	7 weeks

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Repetitive transcranial magnetic stimulation; Stroke rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: rTMS_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No