RecruitingNot ApplicableNCT07007884

Effect of Transauricular Vagal Stimulation on Cardiac Function After Spinal Cord Injury

The Effect of Transauricular Vagal Nerve Stimulation (taVNS) on Cardiac Autonomic Functions in Patients With Spinal Cord Injury

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Enrollment

30 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury (SCI)

Summary

The aim of this study is to investigate the effect of transauricular vagal nerve stimulation (taVNS) on cardiac autonomic functions in patients with spinal cord injury (SCI).

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

Aged between 18-60
Having a traumatic spinal cord injury
Cervical spinal cord injury patients with a history of autonomic dysreflexia
At least 6 months after the injury
Signing an informed consent form showing consent to participate in the study

Exclusion Criteria7

Having a cardiac or neural pacemaker
Presence of pregnancy
Clinical coronary artery disease confirmed by invasive or coronary computed tomographic angiography
History of acute coronary syndrome (unstable angina, myocardial infarction)
Documented arrhythmia and/or use of antiarrhythmic drugs on ECG
Diagnosis of hypertension and use of antihypertensive drugs
Damaged skin lesion in the application area

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Interventions

DEVICEActive Transauricular Vagus Nerve Stimulation

Active taVNS application was performed by stimulating a sterile acupuncture needle (0.25x25 mm) placed on the left ear cymba choncae with a stimulator. Active taVNS group received for 10 days, 30 minutes with a current intensity of 1 mA, pulse width of 200 µs, frequency of 25 Hz and biphasic sinusoidal waveform. In the sham group, stimulation was applied to the lobulus auriculae of the left ear (which is not innervated by the vagus nerve) using the same current intensity and duration as the active group.

DEVICESham Transauricular Vagus Nerve Stimulation

Sham taVNS application was performed by stimulating a sterile acupuncture needle (0.25x25 mm) placed on the left lobulus auriculae of the left ear (which is not innervated by the vagus nerve) with a stimulator. Sham taVNS group received for 10 days, 30 minutes with a current intensity of 1 mA, pulse width of 200 µs, frequency of 25 Hz and biphasic sinusoidal waveform.