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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Frequency Experimental Group | Experimental | 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 |
|
| High Frequency Experimental Group | Experimental | Participants in this Arm will receive 10 sessions of High Frequency (10 Hz) rTMS |
|
| Sham Stimulation Control Group | Sham Comparator | Participants in this Arm will receive 10 sessions of Sham rTMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation therapy that modulates brain excitability. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Petrusevičienė, MD | Contact | +37064410732 | lciginskaite@gmail.com | |
| Raimondas Savickas, Professor | Contact | +37068619797 | raimondas.savickas@lsmuni.lt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Recruiting | Kaunas | 44307 | Lithuania |
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| Sham Transcranial Magnetic Stimulation | Device | During Sham Transcranial Magnetic Stimulation the coil will be facing the wall making the stimulation inactive |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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