Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Motor Function in Stroke Patients
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedDecember 12, 2022
December 1, 2022
4.6 years
October 25, 2022
December 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Change of Functional Independence Measure (FIM) test score.
7 weeks
Study Arms (3)
Low Frequency Experimental Group
EXPERIMENTALParticipants 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
High Frequency Experimental Group
EXPERIMENTALParticipants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS
Sham Stimulation Control Group
SHAM COMPARATORParticipants in this Arm will receive 10 sessions of Sham rTMS
Interventions
Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability.
During Sham Transcranial Magnetic Stimulation the coil will be facing the wall making the stimulation inactive
Eligibility Criteria
You may qualify if:
- 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).
- No severe deficit in cognitive functions.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lithuanian University of Health Sciences
Kaunas, 44307, Lithuania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 25, 2022
First Posted
December 12, 2022
Study Start
June 1, 2021
Primary Completion
January 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 12, 2022
Record last verified: 2022-12