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).
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
- Recruiting
SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Ankara
Ayşenur Şimşek Yağlıoğlu, +903122912455, aysenursimsek33@gmail.com
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.
- Conditions
- Spinal Cord Injury (SCI)
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Device: Active Transauricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted6 Jun 2025
- Study start20 Mar 2024
- Primary completion16 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur ŞİMŞEK YAĞLIOĞLU, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transauricular Vagal Nerve Stimulation (taVNS) on Cardiac Autonomic Functions in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07007884
- Acronym / sponsor ID
- E2-23-3620
- Conditions
- Spinal Cord Injury (SCI)
- Keywords
- vagus nerve stimülation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 16 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cervical spinal cord injury - Active taVNS | Experimental | Device: Active Transauricular Vagus Nerve StimulationThe 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). |
| Cervical spinal cord injury - Sham taVNS | Experimental | Device: Sham Transauricular Vagus Nerve StimulationThe 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). |
| Lumbar spinal cord injury (Cauda Equina Syndrome)- Active taVNS | Experimental | Device: Active Transauricular Vagus Nerve StimulationThe 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transauricular Vagus Nerve StimulationAlso: taVNS, auricular VNSActive 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. | Device | Cervical spinal cord injury - Active taVNS, Lumbar spinal cord injury (Cauda Equina Syndrome)- Active taVNS |
| Sham Transauricular Vagus Nerve StimulationSham 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. | Device | Cervical spinal cord injury - Sham taVNS |
Primary outcome
Low frequency/ High frequency (LF/HF)
Time frame: 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.
14 secondary outcomes
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
Heart rate response to the Valsalva maneuver (Valsalva ratio)
Time frame: At baseline (Day 0) and Day 11
Respiratory heart rate variability
Time frame: At baseline (Day 0) and Day 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
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.