The Effect of Repetitive Transcranial Magnetic Stimulation on Cardiac Autonomic Dysfunction in Patients With Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Heart Rate Variability (HRV) Assessment at the 4th week
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
First Group
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.
Intervention: rTMS M1 Motor Cortex Protocol (Device)
Second Group
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.
Intervention: Sham rTMS Protocol (Device)
Outcomes
Primary Outcomes
Change from Baseline in Heart Rate Variability (HRV) Assessment at the 4th week
Time Frame: Baseline and after final rTMS session( at 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.
Secondary Outcomes
- Change from baseline in Brunnstrom Stage Assessment at the 4th week(Baseline and after final rTMS session( at 4th week))
- Change from baseline in Modified Ashworth Scale (MAS) Assessment at the 4th week(Baseline and after final rTMS session( at 4th week))
- Change from baseline in Stroke-Specific Quality of Life Scale (SSQOL) at the 4th week(Baseline and after final rTMS session( at 4th week))
- Change from baseline in Grip Strength at the 4th week(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(Baseline and after final rTMS session( at 4th week))
- Change from baseline in Blood Pressure Measurement at the 4th week(Baseline and after final rTMS session( at 4th week))
Investigators
Nuran Eyvaz
Medical Doctor
Afyonkarahisar Health Sciences University