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

Not Applicable

Recruiting

Interventions: Device: Repetitive Transcranial Magnetic Stimulation
Device: Sham Transcranial Magnetic Stimulation

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
High Frequency Experimental Group	Repetitive Transcranial Magnetic Stimulation	Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS
Low Frequency Experimental Group	Repetitive Transcranial Magnetic Stimulation	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
Sham Stimulation Control Group	Sham Transcranial Magnetic Stimulation	Participants in this Arm will receive 10 sessions of Sham rTMS

Primary Outcome Measures

Name	Time	Method
Change of hand grip strength	7 weeks	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.
Change of box and block test (BBT) score	7 weeks	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.
Change of upper limb motor score in Fugl-Meyer Assessment	7 weeks	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.
Change of Nine Hole Peg Test (9HPT) score	7 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Change of Functional Independence Measure (FIM) test score.	7 weeks	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.

Locations (1): Lithuanian University of Health Sciences
🇱🇹
Kaunas, Lithuania