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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Enrolling

Conditions: Spinal Cord Injury (SCI)

Treatments: Device: Active Transauricular Vagus Nerve Stimulation; Device: Sham Transauricular Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07007884

E2-23-3620

Details and patient eligibility

About

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).

Full description

Spinal cord injury impairs autonomic pathways and ultimately cardiovascular homeostasis. Spinal cord injury affects the autonomic system, resulting in impaired cardiac autonomic functions. This study is designed to evaluate the effect of transauricular vagal nerve stimulation (taVNS) on cardiac autonomic functions in patients with spinal cord injury.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Cervical spinal cord injury - Active taVNS

Experimental group

Description:

The study included 30 traumatic spinal cord injury (SCI) patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active transaurikular vagal nerve stimülation (taVNS) group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).

Treatment:

Device: Active Transauricular Vagus Nerve Stimulation

Cervical spinal cord injury - Sham taVNS

Experimental group

Description:

The study included 30 traumatic SCI patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active taVNS group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).

Treatment:

Device: Sham Transauricular Vagus Nerve Stimulation

Lumbar spinal cord injury (Cauda Equina Syndrome)- Active taVNS

Experimental group

Description:

The study included 30 traumatic spinal cord injury (SCI) patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active taVNS group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).

Treatment:

Device: Active Transauricular Vagus Nerve Stimulation