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

Primary Purpose

Stroke, Ischemic

Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Stroke, Stroke rehabilitation, Repetitive transcranial magnetic stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lithuanian University of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Low Frequency Experimental Group

High Frequency Experimental Group

Sham Stimulation Control Group

Arm 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

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

Participants in this Arm will receive 10 sessions of Sham rTMS

Outcomes

Primary Outcome Measures

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.
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).
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 25, 2022
Last Updated
December 2, 2022
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05646134
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

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

5. Study Description

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: Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients. 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: Whether repetitive transcranial magnetic stimulation (rTMS) has a positive effect on upper extremity motor function in stroke patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Stroke, Stroke rehabilitation, Repetitive transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Frequency Experimental Group
Arm Type
Experimental
Arm 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
Arm Title
High Frequency Experimental Group
Arm Type
Experimental
Arm Description
Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS
Arm Title
Sham Stimulation Control Group
Arm Type
Sham Comparator
Arm Description
Participants in this Arm will receive 10 sessions of Sham rTMS
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Magnetic Stimulation
Intervention Description
During Sham Transcranial Magnetic Stimulation the coil will be facing the wall making the stimulation inactive
Primary Outcome Measure Information:
Title
Change of upper limb motor score in Fugl-Meyer Assessment
Description
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.
Time Frame
7 weeks
Title
Change of Nine Hole Peg Test (9HPT) score
Description
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).
Time Frame
7 weeks
Title
Change of box and block test (BBT) score
Description
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.
Time Frame
7 weeks
Title
Change of hand grip strength
Description
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.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Change of Functional Independence Measure (FIM) test score.
Description
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.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Petrusevičienė, MD
Phone
+37064410732
Email
lciginskaite@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raimondas Savickas, Professor
Phone
+37068619797
Email
raimondas.savickas@lsmuni.lt
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
ZIP/Postal Code
44307
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judita Tuzaitė
Phone
+370 32 72 01
Email
rektoratas@lsmuni.lt

12. IPD Sharing Statement

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

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