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Recruiting NCT07007884

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

No phase Interventional Spinal Cord Injury (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Transauricular Vagus Nerve Stimulation, Sham Transauricular Vagus Nerve Stimulation.
Who it may be relevant to
Registry conditions: Spinal Cord Injury (SCI). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Active 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 acti
  • Device Sham 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.

Primary outcome measures

  • Low frequency/ High frequency (LF/HF) [Time frame: At baseline (Day 0), Day 1, Day 10, and Day 11]
Secondary outcome measures (12)
  • Total Power [Time frame: At baseline (Day 0) and Day 11]
  • Ultra Low Frequency (ULF) [Time frame: At baseline (Day 0) and Day 11]
  • Very Low Frequency (VLF) [Time frame: At baseline (Day 0) and Day 11]
  • Low Frequency (LF) [Time frame: At baseline (Day 0), Day 1, Day 10, and Day 11]
  • High Frequency (HF) [Time frame: At baseline (Day 0), Day 1, Day 10, and Day 11]
  • SDNN: Standard Deviation of NN intervals [Time frame: At baseline (Day 0) and Day 11]
  • SDNNi: Mean of the standard deviations of all NN intervals for all 5-minute segments [Time frame: At baseline (Day 0) and Day 11]
  • SDANN: Standard deviation of the averages of NN intervals in all 5-minute segments [Time frame: At baseline (Day 0) and Day 11]
  • RMSSD: Root Mean Square of the Successive Differences [Time frame: At baseline (Day 0) and Day 11]
  • pNN50: Percentage of successive NN intervals that differ by more than 50 ms [Time frame: At baseline (Day 0) and Day 11]
  • Heart rate response to the tilt test [Time frame: At baseline (Day 0) and Day 11]
  • Blood pressure response to the tilt test [Time frame: At baseline (Day 0) and Day 11]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Turkey (Türkiye) · 1 center
  • SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi — Ankara

Identifiers

NCT: NCT07007884 · E2-23-3620

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗