Clinical trial NCT05646134: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Motor Function in Stroke Patients
Official title: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Motor Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Stroke
Stroke rehabilitation
Repetitive transcranial magnetic stimulation
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of upper limb motor score in Fugl-Meyer Assessment
timeFrame: 7 weeks
measure: Change of Nine Hole Peg Test (9HPT) score
timeFrame: 7 weeks
measure: Change of box and block test (BBT) score
timeFrame: 7 weeks
measure: Change of hand grip strength
timeFrame: 7 weeks
Secondary outcomes:
measure: Change of Functional Independence Measure (FIM) test score.
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
References: