An interventional study of rTMS M1 Motor Cortex Protocol and Sham rTMS Protocol in Stroke, Autonomic Dysfunction and Hemiparesis, sponsored by Afyonkarahisar Health Sciences University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Afyonkarahisar Health Sciences University · Not applicable, Interventional, and Treatment
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 44 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Afyonkarahisar Health Sciences University is the lead sponsor of 115 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: rTMS M1 Motor Cortex Protocol
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.
Device: Sham rTMS Protocol
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.
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 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.
Time frame: Baseline and after final rTMS session( at 4th week)
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.
Time frame: Baseline and after final rTMS session( at 4th week)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and after final rTMS session( at 4th week)
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