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The aim of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) added to conventional neurological rehabilitation on heart rate variability (HRV), quality of life, upper extremity muscle strength and autonomic symptoms in patients with stroke.
Stroke is a leading cause of disability worldwide and is frequently associated with autonomic dysfunction (AD). AD can affect heart function, arterial blood pressure, fluid balance, and other body systems, negatively influencing clinical outcomes and prognosis. Brain damage in cortical and subcortical regions during stroke can disrupt the integrity of the central autonomic network, leading to AD. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method thought to support neuroplasticity and potentially improve autonomic function. This study aims to investigate the effects of rTMS on autonomic dysfunction and related functional parameters in patients with stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Group | Experimental | In addition to the neurological rehabilitation program (5 days per week, for 4 weeks totaling 20 sessions) repetitive transcranial magnetic stimulation (rTMS) will be applied using the MagVenture MagPro R30 device, with a Figure Eight Coil, according to the study protocol. rTMS will be delivered to the contralateral primary motor cortex (M1) upper extremity motor area at a low frequency of 1 Hz, with 5 sessions per week for 4 weeks, totaling 20 sessions. |
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| Second Group | Sham Comparator | Participants will receive the neurological rehabilitation program in the same form and dosage as applied in the active group. In addition, sham (placebo) repetitive transcranial magnetic stimulation (rTMS) will be administered to mimic the procedure without delivering active stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS M1 Motor Cortex Protocol | Device | Repetitive transcranial magnetic stimulation (rTMS) will be applied using the MagVenture MagPro R30 device with a Figure Eight Coil according to the study protocol. rTMS will be delivered to the contralateral primary motor cortex (M1) upper extremity motor area at a low frequency of 1 Hz, 5 sessions per week for 4 weeks, totaling 20 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Heart Rate Variability (HRV) Assessment at the 4th week | 24-hour Holter monitoring, also known as ambulatory electrocardiography, records the heart rhythm continuously over a 24-hour period using electrodes placed on the patient's chest during daily activities. A three-channel Holter device collects data from three different leads. Heart rate variability (HRV), reflecting autonomic nervous system function and cardiovascular regulation, is calculated from the Holter recordings. Continuous Electrocardiography (ECG) data are analyzed by precisely calculating R-R intervals and removing ectopic beats. HRV parameters are then computed using specialized software or statistical programs. Recordings will be obtained at baseline and final repetitive transcranial magnetic stimulation (rTMS) sessions, and HRV parameters will be calculated separately. | Baseline and after final rTMS session( at 4th week) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Brunnstrom Stage Assessment at the 4th week | The Brunnstrom Stage assesses motor recovery in hemiplegic patients. The neurophysiological recovery process is classified into six stages. Higher Brunnstrom levels are associated with better clinical outcomes. | Baseline and after final rTMS session( at 4th week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ülkü demir | Contact | 5423541114 | ulkudemir_44@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Afyonkarahisar Health Science University | Recruiting | Afyonkarahisar | 0300 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11231036 | Result | Yoshida T, Yoshino A, Kobayashi Y, Inoue M, Kamakura K, Nomura S. Effects of slow repetitive transcranial magnetic stimulation on heart rate variability according to power spectrum analysis. J Neurol Sci. 2001 Feb 15;184(1):77-80. doi: 10.1016/s0022-510x(00)00505-0. | |
| 17490754 | Result | Udupa K, Sathyaprabha TN, Thirthalli J, Kishore KR, Raju TR, Gangadhar BN. Modulation of cardiac autonomic functions in patients with major depression treated with repetitive transcranial magnetic stimulation. J Affect Disord. 2007 Dec;104(1-3):231-6. doi: 10.1016/j.jad.2007.04.002. Epub 2007 May 8. |
| Label | URL |
|---|---|
| Effects of slow repetitive transcranial magnetic stimulation on heart rate variability according to power spectrum analysis | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D054969 | Primary Dysautonomias |
| D010291 | Paresis |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham rTMS Protocol | Device | Sham (placebo) repetitive transcranial magnetic stimulation (rTMS) will be applied to mimic the procedure without delivering active stimulation. It was planned to apply it daily for 20 sessions. |
|
| Change from baseline in Modified Ashworth Scale (MAS) Assessment at the 4th week |
Modified Ashworth Scale (MAS) will measure spasticity in the limbs. MAS evaluates muscle tone on a 0-4 scale: Higher scores represent spasticity or increased resistance to passive movement. All variables are rated on a scale ranging from 0 to 4: 0 means no increase in muscle tone (better outcome) and 4 means rigid (worse outcome). |
| Baseline and after final rTMS session( at 4th week) |
| Change from baseline in Stroke-Specific Quality of Life Scale (SSQOL) at the 4th week | SSQOL is a patient-centered, stroke-specific quality of life measure consisting of 49 items across 12 sub domains. Each domain has at least 3 items scored on a 5-point Likert scale considering the past week. Higher scores indicate better function. The scale is validated and reliable for the Turkish population. | Baseline and after final rTMS session( at 4th week) |
| Change from baseline in Grip Strength at the 4th week | Grip strength measurements are performed after the patient is appropriately positioned. Three measurements are taken with 5-second intervals and averaged. Grip strength is measured bilaterally and the maximum voluntary contraction is recorded in kilograms. | Baseline and after final rTMS session( at 4th week) |
| Change from baseline in Composite Autonomic Symptom Score 31(COMPASS 31) Scoring Test at the 4th week | COMPASS-31 is a 31-item self-report questionnaire designed to assess autonomic nervous system function and the severity of autonomic dysfunction. The scale evaluates symptoms across six domains. Responses are weighted and summed to produce a total score ranging from 0 to 100, with higher scores indicating more severe autonomic dysfunction. | Baseline and after final rTMS session( at 4th week) |
| Change from baseline in Blood Pressure Measurement at the 4th week | Blood pressure will be measured by trained personnel using calibrated auscultatory or oscillometric sphygmomanometers in a quiet, temperature-controlled environment. Participants will avoid food, caffeine, smoking, alcohol, and exercise for at least 30 minutes before measurement. Measurements will be taken twice in each arm, averaged, and the higher value will be recorded. | Baseline and after final rTMS session( at 4th week) |
| 25136660 | Result | Cabrerizo M, Cabrera A, Perez JO, de la Rua J, Rojas N, Zhou Q, Pinzon-Ardila A, Gonzalez-Arias SM, Adjouadi M. Induced effects of transcranial magnetic stimulation on the autonomic nervous system and the cardiac rhythm. ScientificWorldJournal. 2014;2014:349718. doi: 10.1155/2014/349718. Epub 2014 Jul 17. |
| Modulation of cardiac autonomic functions in patients with major depression treated with repetitive transcranial magnetic stimulation | View source |
| Induced effects of transcranial magnetic stimulation on the autonomic nervous system and the cardiac rhythm | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |