Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction

NCT07482501 | Recruiting

• 1 other identifier: TMSCAD2026
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Autonomic Dysfunction; Hemiparesis

Keywords

Repetitive Transcranial Magnetic Stimulation; Hemiplegia; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• 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)

Study Arms (2)

First Group

EXPERIMENTAL

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

Second Group

SHAM COMPARATOR

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

Interventions

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.

First Group

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.

Second Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, 0300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 11231036 RESULT

• 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.

  PMID: 17490754 RESULT

• 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.

  PMID: 25136660 RESULT

Related Links

• Effects of slow repetitive transcranial magnetic stimulation on heart rate variability according to power spectrum analysis
• Modulation of cardiac autonomic functions in patients with major depression treated with repetitive transcranial magnetic stimulation
• Induced effects of transcranial magnetic stimulation on the autonomic nervous system and the cardiac rhythm

MeSH Terms

Conditions

Stroke; Primary Dysautonomias; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Central Study Contacts

ülkü demir

CONTACT

5423541114; ulkudemir_44@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: March 26, 2026
• Primary Completion: June 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)