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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 active group.

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.

Study 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

Primary outcome measure(s)

• Low frequency/ High frequency (LF/HF) — At baseline (Day 0), Day 1, Day 10, and Day 11
  Heart rate variability (HRV) is considered an indicator of neural control over the heart and is measured by analyzing the variations in NN intervals between consecutive R waves on an electrocardiogram (ECG).Frequency-domain analyses determine the power of fluctuations in heart rate signals within specific frequency bands. This analysis can be conducted using short-term Holter ECG recordings or data from 5-minute segments of a 24-hour Holter ECG. In our study, the short-term effects of taVNS on frequency domain HRV parameters will be evaluated using data obtained from 24-hour Holter ECG recordings on the pre-stimulation day (day 0) and day 11, and the acute effects will be assessed using data from 15-minute Holter recordings on day 1 and day 10.The LF/HF ratio is also one of the frequency-domain HRV parameters. LF/HF (ratio): low-to-high frequency power ratio The LF/HF ratio serves as an indicator of sympathovagal balance.

Trial sites (1)

More Gaziler Physical Medicine and Rehabilitation Education and Research Hospital trials in Turkey