Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction

June 24, 2026 updated by: Nuran Eyvaz, Afyonkarahisar Health Sciences University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and after final rTMS session( at 4th week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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).
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)
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.
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)
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.
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)
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.
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)
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.
Baseline and after final rTMS session( at 4th week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Afyonkarahisar Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMSCAD2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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