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

NCT07007884 | Recruiting

• 1 other identifier: E2-23-3620
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injury (SCI)

Keywords

vagus nerve stimülation

Outcome Measures

Primary Outcomes (1)

• Low frequency/ High frequency (LF/HF)

  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.

  At baseline (Day 0), Day 1, Day 10, and Day 11

Secondary Outcomes (14)

• Total Power

  At baseline (Day 0) and Day 11

• Ultra Low Frequency (ULF)

  At baseline (Day 0) and Day 11

• Very Low Frequency (VLF)

  At baseline (Day 0) and Day 11

• Low Frequency (LF)

  At baseline (Day 0), Day 1, Day 10, and Day 11

• High Frequency (HF)

  At baseline (Day 0), Day 1, Day 10, and Day 11

Study Arms (3)

Cervical spinal cord injury - Active taVNS

EXPERIMENTAL

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).

Device: Active Transauricular Vagus Nerve Stimulation

Cervical spinal cord injury - Sham taVNS

EXPERIMENTAL

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).

Device: Sham Transauricular Vagus Nerve Stimulation

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

EXPERIMENTAL

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).

Device: Active Transauricular Vagus Nerve Stimulation

Interventions

Active Transauricular Vagus Nerve Stimulation DEVICE

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.

Also known as: taVNS, auricular VNS

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

Sham Transauricular Vagus Nerve Stimulation DEVICE

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.

Cervical spinal cord injury - Sham taVNS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 6, 2025
• Study Start: March 20, 2024
• Primary Completion: July 16, 2025
• Study Completion: September 30, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

TU (1)