Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS M1 Motor Cortex Protocol, Sham rTMS Protocol.
- Who it may be relevant to
- Registry conditions: Stroke, Autonomic Dysfunction, Hemiparesis. Basic parameters: 35 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Repetitive Transcranial Magnetic Stimulation on Cardiac Autonomic Dysfunction in Patients With Stroke
Overview
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.
Detailed description
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.
Interventions
- Device rTMS M1 Motor Cortex 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. - Device Sham rTMS Protocol
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.
Primary outcome measures
- Change from Baseline in Heart Rate Variability (HRV) Assessment at the 4th week [Time frame: Baseline and after final rTMS session( at 4th week)]
Secondary outcome measures (6)
- Change from baseline in Brunnstrom Stage Assessment at the 4th week [Time frame: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Modified Ashworth Scale (MAS) Assessment at the 4th week [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 [Time frame: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Grip Strength at the 4th week [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 [Time frame: Baseline and after final rTMS session( at 4th week)]
- Change from baseline in Blood Pressure Measurement at the 4th week [Time frame: Baseline and after final rTMS session( at 4th week)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Serious cardiac disease, uncontrolled hypertension
- Epilepsy or history of antiepileptic drug use
- Intracranial metallic implants
- Inner ear implants
- Malignancy
- Active infection
- Skin infection or open wound in the intervention area
- Brain lesions or medications that may alter the seizure threshold
- Increased intracranial pressure
- Uncontrolled migraine
- Fracture or surgery on the hemiplegic side within the last 6 months
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Afyonkarahisar Health Science University — Afyonkarahisar
Publications
- 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. PMID 11231036
- 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. PMID 17490754
- 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. PMID 25136660
Identifiers
NCT: NCT07482501 · TMSCAD2026