Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07482501

Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Science University

Afyonkarahisar, 0300, Turkey (Türkiye)

Location status: Recruiting

Location contact

ülkü demir

CONTACT

[email protected]

5423541114

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS M1 Motor Cortex Protocol

Device

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 rTMS Protocol

Device

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 outcomes

  1. 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

  1. Change from baseline in Brunnstrom Stage Assessment at the 4th week

    Time frame: 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.

  2. Change from baseline in Modified Ashworth Scale (MAS) Assessment at the 4th week

    Time frame: 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).

  3. 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)

    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.

  4. Change from baseline in Grip Strength at the 4th week

    Time frame: 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.

  5. 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)

    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.

  6. Change from baseline in Blood Pressure Measurement at the 4th week

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ülkü demir

CONTACT

[email protected]

5423541114

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

The Effect of Repetitive Transcranial Magnetic Stimulation on Cardiac Autonomic Dysfunction in Patients With Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.