Spinal Cord Injury, ChronictaVNS-HRV-SCINCT07524491
taVNS During Exercise and Recovery in Chronic Spinal Cord Injury
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Spinal Cord Injury, Chronic, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic cardiovascular regulation during exercise and recovery in individuals with chronic spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Chronic
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 31 Oct 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with chronic spinal cord injury
- Medically stable condition
- Ability to perform the exercise protocol
- Ability to provide informed consent
Who cannot join
- Acute spinal cord injury
- Severe cardiovascular or respiratory instability
- Use of medications significantly affecting autonomic function
- Skin lesions or contraindications to transcutaneous stimulation
- Cognitive impairment preventing protocol compliance
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation Modulates Autonomic Dynamics During Exercise and Recovery in Chronic Spinal Cord Injury
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic cardiovascular regulation during exercise and recovery in individuals with chronic spinal cord injury (SCI). Participants undergo two experimental conditions (active taVNS and sham stimulation) in a randomized crossover design while performing a standardized exercise protocol.
Heart rate variability (HRV) is used as a non-invasive biomarker to assess autonomic nervous system dynamics across different phases (baseline, exercise, and recovery). The aim is to characterize physiological responses to neuromodulation and explore whether taVNS modulates autonomic adaptability in this population.
This is a mechanistic physiological study designed to improve the understanding of autonomic regulation in SCI and to explore potential biomarkers of response to neuromodulation.
Read the detailed description
Spinal cord injury (SCI) is associated with significant impairments in autonomic nervous system function, particularly affecting cardiovascular regulation. These alterations reduce physiological adaptability to internal and external stressors and may contribute to increased cardiovascular risk.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that has been proposed as a potential tool to influence autonomic function. However, its effects on dynamic autonomic regulation during physiological stress, such as exercise, remain insufficiently characterized in individuals with SCI.
The present study is a randomized, controlled, crossover experimental protocol designed to investigate the acute effects of taVNS on autonomic cardiovascular dynamics during a structured exercise and recovery paradigm. Participants with chronic SCI are exposed to two conditions: active taVNS and sham stimulation, applied in a randomized order.
Each experimental session includes three phases: baseline (rest), exercise (submaximal effort), and recovery. Continuous electrocardiographic recordings are obtained to derive heart rate variability (HRV) metrics. Both linear (time and frequency domain) and non-linear analyses are performed to characterize autonomic regulation and system dynamics.
The primary objective is to evaluate whether taVNS modulates autonomic responsiveness and adaptability across different physiological states. Secondary objectives include the exploration of HRV-derived biomarkers that may reflect autonomic complexity and the identification of response patterns to neuromodulation.
This study is not designed to evaluate clinical efficacy or therapeutic outcomes but to provide mechanistic insight into autonomic regulation and neuromodulation effects in SCI. The results may contribute to the development of personalized approaches in neurorehabilitation and autonomic monitoring.
- Conditions
- Spinal Cord Injury, Chronic
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Sham Stimulation
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Heart rate variability, Autonomic nervous system, Neuromodulation, Spinal cord injury, Exercise physiology, Nonlinear dynamics
- Medical subject headings
- Spinal Cord Injuries, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Non-invasive electrical stimulation applied to the auricular branch of the vagus nerve using transcutaneous electrodes during the experimental protocol.
Sham StimulationDevice
Sham stimulation delivered with identical device setup but without effective activation of the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS | Experimental | Transcutaneous auricular vagus nerve stimulation applied during the experimental protocol. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham Stimulation | Sham comparator | Sham stimulation applied under identical experimental conditions without effective vagus nerve activation. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFA α2
Detrended fluctuation analysis (α2) derived from RR intervals to assess long-term fractal scaling properties of heart rate variability. RR intervals are recorded continuously and analyzed offline. Data are processed using 5-minute overlapping windows. The value reported at each specific time point represents the calculation for the preceding 5-minute window to characterize autonomic regulation across the session.
Measured: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
Secondary outcomes (4)
RMSSD (ms)
Root mean square of successive differences (RMSSD) of RR intervals to assess short-term heart rate variability and parasympathetic activity. RR intervals are recorded continuously and analyzed offline. Data are processed using 5-minute overlapping windows. The value reported at each time point represents the calculation for the preceding 5-minute window..
Measured: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
HF power (ms²)
High-frequency (HF) power (0.15-0.40 Hz) derived from RR intervals to assess parasympathetic modulation. Spectral analysis is performed using standard frequency-domain methods. Data are processed using 5-minute overlapping windows. Each reported value corresponds to the preceding 5-minute window at the specified time point.
Measured: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
LF power (ms²)
Low-frequency (LF) power (0.04-0.15 Hz) derived from RR intervals to assess combined autonomic modulation. Frequency-domain analysis is performed after preprocessing of RR interval data. Data are processed using 5-minute overlapping windows. Each reported value corresponds to the preceding 5-minute window at the specified time point.
Measured: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
SD1 (ms)
SD1 derived from the Poincaré plot of RR intervals, representing short-term beat-to-beat variability. RR intervals are recorded continuously and analyzed offline. Data are processed using 5-minute overlapping windows. Each reported value corresponds to the preceding 5-minute window at the specified time point.
Measured: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Oct 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury, ChronicStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, crossover experimental study with two conditions (active taVNS and sham). Each participant undergoes both conditions during standardized exercise and recovery phases.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Institute of the Balearic Islands (IdISBa, Spain)
- Responsible party
- Principal investigator, Maria Cristina Nicolau Llobera, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524491
- Sponsor's protocol ID
- UIB-taVNS-SCI-2024
- Other IDs
- 19CER24
- Acronym
- taVNS-HRV-SCI
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and ethical considerations. Aggregated data may be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation Modulates Autonomic Dynamics During Exercise and Recovery in Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07524491
- Acronym / sponsor ID
- taVNS-HRV-SCI / UIB-taVNS-SCI-2024
- Conditions
- Spinal Cord Injury, Chronic
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Heart rate variability, Autonomic nervous system, Neuromodulation, Spinal cord injury, Exercise physiology, Nonlinear dynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Health Research Institute of the Balearic Islands (IdISBa, Spain)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 13 Apr 2026 (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.
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic cardiovascular regulation during exercise and recovery in individuals with chronic spinal cord injury (SCI). Participants undergo two experimental conditions (active taVNS and sham stimulation) in a randomized crossover design while performing a standardized exercise protocol.
Heart rate variability (HRV) is used as a non-invasive biomarker to assess autonomic nervous system dynamics across different phases (baseline, exercise, and recovery). The aim is to characterize physiological responses to neuromodulation and explore whether taVNS modulates autonomic adaptability in this population.
This is a mechanistic physiological study designed to improve the understanding of autonomic regulation in SCI and to explore potential biomarkers of response to neuromodulation.
Detailed description
Spinal cord injury (SCI) is associated with significant impairments in autonomic nervous system function, particularly affecting cardiovascular regulation. These alterations reduce physiological adaptability to internal and external stressors and may contribute to increased cardiovascular risk.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that has been proposed as a potential tool to influence autonomic function. However, its effects on dynamic autonomic regulation during physiological stress, such as exercise, remain insufficiently characterized in individuals with SCI.
The present study is a randomized, controlled, crossover experimental protocol designed to investigate the acute effects of taVNS on autonomic cardiovascular dynamics during a structured exercise and recovery paradigm. Participants with chronic SCI are exposed to two conditions: active taVNS and sham stimulation, applied in a randomized order.
Each experimental session includes three phases: baseline (rest), exercise (submaximal effort), and recovery. Continuous electrocardiographic recordings are obtained to derive heart rate variability (HRV) metrics. Both linear (time and frequency domain) and non-linear analyses are performed to characterize autonomic regulation and system dynamics.
The primary objective is to evaluate whether taVNS modulates autonomic responsiveness and adaptability across different physiological states. Secondary objectives include the exploration of HRV-derived biomarkers that may reflect autonomic complexity and the identification of response patterns to neuromodulation.
This study is not designed to evaluate clinical efficacy or therapeutic outcomes but to provide mechanistic insight into autonomic regulation and neuromodulation effects in SCI. The results may contribute to the development of personalized approaches in neurorehabilitation and autonomic monitoring.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled, crossover experimental study with two conditions (active taVNS and sham). Each participant undergoes both conditions during standardized exercise and recovery phases.
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationTranscutaneous auricular vagus nerve stimulation applied during the experimental protocol. |
| Sham Stimulation | Sham comparator | Device: Sham StimulationSham stimulation applied under identical experimental conditions without effective vagus nerve activation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years) with chronic spinal cord injury
- Medically stable condition
- Ability to perform the exercise protocol
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Acute spinal cord injury
- Severe cardiovascular or respiratory instability
- Use of medications significantly affecting autonomic function
- Skin lesions or contraindications to transcutaneous stimulation
- Cognitive impairment preventing protocol compliance
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 |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationNon-invasive electrical stimulation applied to the auricular branch of the vagus nerve using transcutaneous electrodes during the experimental protocol. | Device | Active taVNS |
| Sham StimulationSham stimulation delivered with identical device setup but without effective activation of the vagus nerve. | Device | Sham Stimulation |
Primary outcome
DFA α2
Time frame: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
Detrended fluctuation analysis (α2) derived from RR intervals to assess long-term fractal scaling properties of heart rate variability. RR intervals are recorded continuously and analyzed offline. Data are processed using 5-minute overlapping windows. The value reported at each specific time point represents the calculation for the preceding 5-minute window to characterize autonomic regulation across the session.
4 secondary outcomes
RMSSD (ms)
Time frame: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
HF power (ms²)
Time frame: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
LF power (ms²)
Time frame: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
SD1 (ms)
Time frame: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and ethical considerations. Aggregated data may be available upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Spinal Cord Injury, Chronic, run by University of the Balearic Islands at 1 site in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Apr 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFA α2 (time frame: Baseline (last 5 minutes of rest), 10, 15, 20, 25, 30, 35, and 40 minutes.). 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 13 Apr 2026.