Autonomic Dysfunction, Hemiparesis, Stroke
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation, Hemiplegia, Neurological Rehabilitation
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.
Interventions
DEVICErTMS 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.
DEVICESham 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.
Sponsors
Afyonkarahisar Health Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Heart Rate Variability (HRV) Assessment at the 4th week | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Brunnstrom Stage Assessment at the 4th week | Baseline and after final rTMS session( at 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. |
| Change from baseline in Modified Ashworth Scale (MAS) Assessment at the 4th week | Baseline and after final rTMS session( at 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). |
| Change from baseline in Stroke-Specific Quality of Life Scale (SSQOL) at the 4th week | Baseline and after final rTMS session( at 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. |
| Change from baseline in Grip Strength at the 4th week | Baseline and after final rTMS session( at 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. |
| 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) | 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. |
| Change from baseline in Blood Pressure Measurement at the 4th week | Baseline and after final rTMS session( at 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTülkü demir
Outcome results
None listed