Clinical trial NCT07007884: Effect of Transauricular Vagal Stimulation on Cardiac Function After Spinal Cord Injury
Official title: The Effect of Transauricular Vagal Nerve Stimulation (taVNS) on Cardiac Autonomic Functions in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury (SCI)
Keywords: vagus nerve stimülation
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were divided into groups as group I cervical complete spinal cord injury (SCI) patients in active transauricular vagal nerve stimülation (taVNS) group, group II cervical complete SCI patients in sham taVNS group and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group.
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Low frequency/ High frequency (LF/HF)
timeFrame: At baseline (Day 0), Day 1, Day 10, and Day 11
Secondary outcomes:
measure: Total Power
timeFrame: At baseline (Day 0) and Day 11
measure: Ultra Low Frequency (ULF)
timeFrame: At baseline (Day 0) and Day 11
measure: Very Low Frequency (VLF)
timeFrame: At baseline (Day 0) and Day 11
measure: Low Frequency (LF)
timeFrame: At baseline (Day 0), Day 1, Day 10, and Day 11
measure: High Frequency (HF)
timeFrame: At baseline (Day 0), Day 1, Day 10, and Day 11
measure: SDNN: Standard Deviation of NN intervals
timeFrame: At baseline (Day 0) and Day 11
measure: SDNNi: Mean of the standard deviations of all NN intervals for all 5-minute segments
timeFrame: At baseline (Day 0) and Day 11
measure: SDANN: Standard deviation of the averages of NN intervals in all 5-minute segments
timeFrame: At baseline (Day 0) and Day 11
measure: RMSSD: Root Mean Square of the Successive Differences
timeFrame: At baseline (Day 0) and Day 11
measure: pNN50: Percentage of successive NN intervals that differ by more than 50 ms
timeFrame: At baseline (Day 0) and Day 11
measure: Heart rate response to the tilt test
timeFrame: At baseline (Day 0) and Day 11
measure: Blood pressure response to the tilt test
timeFrame: At baseline (Day 0) and Day 11
measure: Heart rate response to the Valsalva maneuver (Valsalva ratio)
timeFrame: At baseline (Day 0) and Day 11
measure: Respiratory heart rate variability
timeFrame: At baseline (Day 0) and Day 11
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Study officials:
References: