Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorAfyonkarahisar Health Sciences University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged 35-80 years admitted to the Afyonkarahisar Health Sciences University Hospital Physical Medicine and Rehabilitation Unit for neurological rehabilitation after stroke
Participants with a history of stroke of at least 3 months
Neurologically and medically stable participants willing to participate regularly in the study
Participants capable of following commands
Disqualifiers
Serious cardiac disease, uncontrolled hypertension
Epilepsy or history of antiepileptic drug use
Intracranial metallic implants
Inner ear implants
Trial design
Design model
Parallel
Treatments tested in this trial
rTMS M1 Motor Cortex Protocol
DeviceRepetitive 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 rTMS Protocol
DeviceSham (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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: First GroupExperimental treatment 1 intervention
Group B: Second GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov