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StrokeNCT07482501

Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction

A study testing rTMS M1 Motor Cortex Protocol in people with Stroke and Autonomic Dysfunction, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Stroke, Autonomic Dysfunction, Hemiparesis
What is being tested?
rTMS M1 Motor Cortex Protocol
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
26 Mar 2026to 15 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Serious cardiac disease, uncontrolled hypertension
  • Epilepsy or history of antiepileptic drug use
  • Intracranial metallic implants
  • Inner ear implants
  • Malignancy
  • Active infection
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ülkü demir contact

5423541114

ulkudemir_44@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Afyonkarahisar Health Science University

    Afyonkarahisar, 0300

    ülkü demir, 5423541114, ulkudemir_44@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
rTMS M1 Motor Cortex Protocol, Sham rTMS Protocol
Keywords
Repetitive Transcranial Magnetic Stimulation, Hemiplegia, Neurological Rehabilitation
Medical subject headings
Stroke, Primary Dysautonomias, Paresis, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS M1 Motor Cortex ProtocolDevice

    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 ProtocolDevice

    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.

Study groups in NCT07482501
Study groupRoleWhat they receive
First GroupExperimentalIn 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.
Receives: Device: rTMS M1 Motor Cortex Protocol
Second GroupSham comparatorParticipants 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.
Receives: Device: Sham rTMS Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Heart Rate Variability (HRV) Assessment at the 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.

    Measured: Baseline and after final rTMS session( at 4th week)

Secondary outcomes (6)

  1. Change from baseline in Brunnstrom Stage Assessment at the 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.

    Measured: Baseline and after final rTMS session( at 4th week)

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

    Measured: Baseline and after final rTMS session( at 4th week)

  3. Change from baseline in Stroke-Specific Quality of Life Scale (SSQOL) at the 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.

    Measured: Baseline and after final rTMS session( at 4th week)

  4. Change from baseline in Grip Strength at the 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.

    Measured: Baseline and after final rTMS session( at 4th week)

  5. Change from baseline in Composite Autonomic Symptom Score 31(COMPASS 31) Scoring Test at the 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.

    Measured: Baseline and after final rTMS session( at 4th week)

  6. Change from baseline in Blood Pressure Measurement at the 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.

    Measured: Baseline and after final rTMS session( at 4th week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start26 Mar 2026
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07482501
Sponsor's protocol ID
TMSCAD2026
Status last verified
Jun 2026
First submitted
15 Mar 2026
Last updated
25 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 25136660

Questions about this trial

What is this clinical trial studying?

A study testing rTMS M1 Motor Cortex Protocol in people with Stroke and Autonomic Dysfunction, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ülkü demir (5423541114, ulkudemir_44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Heart Rate Variability (HRV) Assessment at the 4th week (time frame: Baseline and after final rTMS session( at 4th week)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07482501, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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