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Spinal Cord Injury (SCI)NCT07007884

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

A study testing Active Transauricular Vagus Nerve Stimulation in people with Spinal Cord Injury (SCI), run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injury (SCI)
What is being tested?
Active Transauricular Vagus Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Mar 2024to 30 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

    Ankara

    Ayşenur Şimşek Yağlıoğlu, +903122912455, aysenursimsek33@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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).

Read the 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.

Being tested
Active Transauricular Vagus Nerve Stimulation, Sham Transauricular Vagus Nerve Stimulation
Keywords
vagus nerve stimülation
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Transauricular Vagus Nerve StimulationDevice

    Also called taVNS, auricular VNS

    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 StimulationDevice

    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 groups in NCT07007884
Study groupRoleWhat they receive
Cervical spinal cord injury - Active taVNSExperimentalThe 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).
Receives: Device: Active Transauricular Vagus Nerve Stimulation
Cervical spinal cord injury - Sham taVNSExperimentalThe 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).
Receives: Device: Sham Transauricular Vagus Nerve Stimulation
Lumbar spinal cord injury (Cauda Equina Syndrome)- Active taVNSExperimentalThe 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).
Receives: Device: Active Transauricular Vagus Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (14)
  1. Total Power

    Frequency-domain heart rate variability (HRV) parameters include Total Power, Ultra Low Frequency (ULF), Very Low Frequency (VLF), Low Frequency (LF), High Frequency (HF), and the Low Frequency/High Frequency (LF/HF) ratio.

    Total power, represents the total power of all frequency components within the frequency spectrum. It is the sum of the very low frequency (VLF), low frequency (LF), and high frequency (HF) components. Total power is an important parameter for the overall evaluation of autonomic nervous system functions.

    In our study, the short-term effects of taVNS on total power will be evaluated using data obtained from 24-hour Holter ECG recordings on the pre-stimulation day (day 0) and on day 11.

    Total power (millisecond²: ms²): Variance of all NN(Normal-to-Normal) intervals (<0.4 Hz)

    Measured: At baseline (Day 0) and Day 11

  2. Ultra Low Frequency (ULF)

    The ULF is also one of the frequency-domain HRV parameters. ULF represents the ultra low frequency. It indicates frequencies <0.003 Hz. It does not directly reflect sympathetic or parasympathetic activity.

    In our study, the short-term effects of taVNS on ULF will be evaluated using data obtained from 24-hour Holter ECG recordings on the pre-stimulation day (day 0) and on day 11.

    ULF (ms²): ultra low frequency (<0.003 Hz)

    Measured: At baseline (Day 0) and Day 11

  3. Very Low Frequency (VLF)

    The VLF is also one of the frequency-domain HRV parameters. VLF represents the very low frequency. It indicates frequencies between <0.003 and 0.04 Hz. It has been associated with baroreceptor activity, thermoregulation, the renin-angiotensin system, and endothelial functions.

    In our study, the short-term effects of taVNS on VLF will be evaluated using data obtained from 24-hour Holter ECG recordings on the pre-stimulation day (day 0) and on day 11.

    VLF (ms²): very low frequency (frequencies between <0.003 and 0.04 Hz)

    Measured: At baseline (Day 0) and Day 11

  4. Low Frequency (LF)

    The LF is also one of the frequency-domain HRV parameters. LF represents the low frequency. It indicates frequencies between 0.04 and 0.15 Hz. It reflects a combination of sympathetic and parasympathetic activity and is particularly associated with sympathetic activity in seated or standing positions.

    In our study, the short-term effects of taVNS on LF will be evaluated using data obtained from 24-hour Holter ECG recordings on the pre-stimulation day (day 0) and on day 11, while the acute effects will be assessed using data from 15-minute Holter recordings on day 1 and day 10.

    LF (ms2): low frequency power (0.04 to 0.15)

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

  5. High Frequency (HF)

    The HF is also one of the frequency-domain HRV parameters. HF represents the high frequency. It indicates frequencies between 0.15 and 0.40 Hz. It reflects parasympathetic activity. An increase in HF indicates a high vagal tone.

    In our study, the short-term effects of taVNS on HF will be evaluated using data obtained from 24-hour Holter ECG recordings on the pre-stimulation day (day 0) and on day 11, while the acute effects will be assessed using data from 15-minute Holter recordings on day 1 and day 10.

    HF (ms²): high frequency power (0.15 to 0.40)

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

  6. SDNN: Standard Deviation of NN intervals

    Time-domain HRV parameters are based on the analysis of the time intervals between normal heartbeats in 24-hour ECG recordings. In our study, the time-domain HRV parameters, including SDNN, SDNNi, SDANN, RMSSD, and pNN50, will be calculated from 24-hour Holter ECG recordings obtained before stimulation and after 10 days of stimulation.

    SDNN (ms): It is the standard deviation of all NN (interval between two adjacent R waves) intervals in the 24-hour ECG recording.

    Measured: At baseline (Day 0) and Day 11

  7. SDNNi: Mean of the standard deviations of all NN intervals for all 5-minute segments

    Time-domain HRV parameters are based on the analysis of the time intervals between normal heartbeats in 24-hour ECG recordings. In our study, the time-domain HRV parameters, including SDNN, SDNNi, SDANN, RMSSD, and pNN50, will be calculated from 24-hour Holter ECG recordings obtained before stimulation and after 10 days of stimulation.

    SDNN index (ms): It is the mean of the standard deviations of all NN intervals for all 5-minute segments within 24 hours.

    Measured: At baseline (Day 0) and Day 11

  8. SDANN: Standard deviation of the averages of NN intervals in all 5-minute segments

    Time-domain HRV parameters are based on the analysis of the time intervals between normal heartbeats in 24-hour ECG recordings. In our study, the time-domain HRV parameters, including SDNN, SDNNi, SDANN, RMSSD, and pNN50, will be calculated from 24-hour Holter ECG recordings obtained before stimulation and after 10 days of stimulation.

    SDANN (ms): The standard deviation of the mean of the normal RR intervals of the 5-minute segments in the 24-hour ECG recording.

    Measured: At baseline (Day 0) and Day 11

  9. RMSSD: Root Mean Square of the Successive Differences

    Time-domain HRV parameters are based on the analysis of the time intervals between normal heartbeats in 24-hour ECG recordings. In our study, the time-domain HRV parameters, including SDNN, SDNNi, SDANN, RMSSD, and pNN50, will be calculated from 24-hour Holter ECG recordings obtained before stimulation and after 10 days of stimulation.

    RMSDD (ms): is the root of the mean of squares of consecutive NN interval differences over the 24-hour recording.

    Measured: At baseline (Day 0) and Day 11

  10. pNN50: Percentage of successive NN intervals that differ by more than 50 ms

    Time-domain HRV parameters are based on the analysis of the time intervals between normal heartbeats in 24-hour ECG recordings. In our study, the time-domain HRV parameters, including SDNN, SDNNi, SDANN, RMSSD, and pNN50, will be calculated from 24-hour Holter ECG recordings obtained before stimulation and after 10 days of stimulation.

    pNN50 (%): The proportion of differences between consecutive NN intervals greater than 50 ms during the 24-hour recording

    Measured: At baseline (Day 0) and Day 11

  11. Heart rate response to the tilt test

    The Ewing's battery parameters (EBP) are the most popular among clinical autonomic test batteries. In our study, the tilt test, heart rate and blood pressure changes, respiratory heart rate changes, and the Valsalva maneuver selected from the EBP clinical autonomic tests.

    This test is used to evaluate the hemodynamic response to changes in body position. When moving from a supine to an upright position, venous pooling in the lower extremities leads to a decrease in stroke volume, resulting in a rapid increase in heart rate within the first 30 seconds. The normal response is characterized by a slight increase in heart rate (by 5-20 beats per minute), and the 30/15 ratio in the test is used to assess the initial phase of adaptation to standing. After tilting to an 80-degree upright position using a tilt table, the ratio of the longest R-R interval around the 30th beat to the shortest R-R interval around the 15th beat is calculated. A ratio lower than 1.04 is considered abnormal.

    Measured: At baseline (Day 0) and Day 11

  12. Blood pressure response to the tilt test

    It is another of the clinical autonomic tests in our study. This is another test used to evaluate the hemodynamic response to changes in body position. When moving from a supine to an upright position, blood moves to the lower extremities, reducing venous return and stroke volume. This test is performed to identify the presence of orthostatic hypotension (OH). After measuring the patient's baseline blood pressure in the supine position, the patient is brought to an 80-degree upright position using a tilt table and is kept in this position for 5 minutes. A decrease in systolic blood pressure by ≥20 mmHg or in diastolic blood pressure by ≥10 mmHg is considered a positive test result.

    Measured: At baseline (Day 0) and Day 11

  13. Heart rate response to the Valsalva maneuver (Valsalva ratio)

    It is another of the clinical autonomic tests in our study. The Valsalva maneuver is a test used to evaluate baroreceptor function and reflects parasympathetic activity. In this test, the patient lies in a supine position with the head elevated to 30 degrees, takes a deep breath, and then performs a forced expiration against a closed airway for 15 seconds, followed by a 45-second rest period of normal breathing. The ratio of the longest R-R interval to the shortest R-R interval is recorded. Three maneuvers are performed, and the average of the three ratios is calculated. A value below 1.2 indicates parasympathetic dysfunction.

    Measured: At baseline (Day 0) and Day 11

  14. Respiratory heart rate variability

    It is another of the clinical autonomic tests in our study. This test is based on the phenomenon of respiratory sinus arrhythmia, which becomes particularly evident when breathing at a rate of six breaths per minute. The test is used to assess the effect of the parasympathetic nervous system on heart rate. In this test, the patient lies in a supine position with the head elevated to 30 degrees and is instructed to breathe in and out six times over one minute, with a 5-second inspiration and a 5-second expiration cycle. The difference between the maximum and minimum heart rate within the one-minute cycle is measured. The cycle is repeated three times, and the average of the heart rate differences is calculated. A variability of less than 10 beats per minute indicates parasympathetic dysfunction.

    Measured: At baseline (Day 0) and Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study start20 Mar 2024
  3. Primary completion16 Jul 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007884
Sponsor's protocol ID
E2-23-3620
Status last verified
Jun 2025
First submitted
21 May 2025
Last updated
6 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Active Transauricular Vagus Nerve Stimulation in people with Spinal Cord Injury (SCI), run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low frequency/ High frequency (LF/HF) (time frame: At baseline (Day 0), Day 1, Day 10, and Day 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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