Spinal Cord Injuries (Complete and Incomplete)Phase 1/2PIVOTS-RehabNCT07562113
Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery
A Phase 1/2 study testing Transauricular vagus nerve stimulation in people with Spinal Cord Injuries (Complete and Incomplete), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Spinal Cord Injuries (Complete and Incomplete)
- What is being tested?
- Transauricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 15 Dec 2027
- Phase
- Phase 1/2
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)
- Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan
Who cannot join
- Phase 1 Age >89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants
- Phase 2 no exclusion criteria for those who meet inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Rachel E Cowan, PhD, 2059345034, recowan@uabmc.edu
Rachel, 2059345034, recowan@uabmc.edu
About this study
Official title: Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation
This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).
This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.
Read more
This study has two main goals:
- To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
- To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.
This study has two parts.
In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.
In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.
- Being tested
- Transauricular vagus nerve stimulation
- Keywords
- vagus nerve stimulation, spinal cord injuries, Rehabilitation, walking
- 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.
Transauricular vagus nerve stimulationDevice
Also called taVNS
bilateral transauricular vagal nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| taVNS application | Experimental | This is a single arm study with two Phases.
In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation
In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists.
All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details. Receives: Device: Transauricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Measured: Immediately before Phase 1 taVNS application
Phase 1 Hypotension Symptoms during taVNS spplication
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Measured: During application of Phase 1 taVNS
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Measured: Immediately after Phase 1 taVNS is stopped
Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Measured: 5 minutes after Phase 1 taVNS is stopped
Phase 1 taVNS Tolerability survey
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Measured: Within 48 hours of competing Phase 1 taVNS
Phase 2 taVNS Tolerability survey
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Measured: Within 48 hours of completing Phase 2 taVNS
Secondary outcomes (6)
Phase 1 Blood Pressure Immediately before taVNS is applied
Systolic and Diastolic Blood Pressure (mmHg)
Measured: Immediately before taVNS Phase 1 application is applied
Phase 1 Blood Pressure during taVNS application
Systolic and Diastolic Blood Pressure (mmHg)
Measured: During taVNS Phase 1 application
Phase 1 Blood Pressure Immediately after taVNS is stopped
Systolic and Diastolic Blood Pressure (mmHg)
Measured: Immediately after taVNS Phase 1 application is stopped
Phase 1 Blood Pressure 5 minutes after taVNS is stopped
Systolic and Diastolic Blood Pressure (mmHg)
Measured: 5 minutes after taVNS Phase 1 application is stopped
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission
Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record
Measured: Admission to rehabilitation
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge
Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record
Measured: Immediately after discharge from rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (Complete and Incomplete)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Cowan, University of Alabama at Birmingham
- Investigators
- Rachel E Cowan, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562113
- Sponsor's protocol ID
- IRB-300015896
- Other IDs
- UAB
- Acronym
- PIVOTS-Rehab
- Status last verified
- Aug 2026
- First submitted
- 6 Apr 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an internally funded study with limited personnel support. Adequate preparation of the data to ensure seamless and rigorous sharing cannot be guaranteed at the time of registration. The investigators may update the plan to share IPD in the future if additional personnel support becomes available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation
- ClinicalTrials.gov ID
- NCT07562113
- Acronym / sponsor ID
- PIVOTS-Rehab / IRB-300015896
- Keywords
- vagus nerve stimulation, spinal cord injuries, Rehabilitation, walking
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 1 May 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 looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).
This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.
This study has two main goals:
- To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
- To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.
This study has two parts.
In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.
In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taVNS application | Experimental | Device: Transauricular vagus nerve stimulationThis is a single arm study with two Phases. In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists. All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)
- Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan
Key exclusion criteria (2 listed)
- Phase 1 Age >89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants
- Phase 2 no exclusion criteria for those who meet inclusion criteria
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 |
|---|---|---|
| Transauricular vagus nerve stimulationAlso: taVNSbilateral transauricular vagal nerve stimulation | Device | taVNS application |
Primary outcome
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Time frame: Immediately before Phase 1 taVNS application
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Phase 1 Hypotension Symptoms during taVNS spplication
Time frame: During application of Phase 1 taVNS
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
Time frame: Immediately after Phase 1 taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
Time frame: 5 minutes after Phase 1 taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Phase 1 taVNS Tolerability survey
Time frame: Within 48 hours of competing Phase 1 taVNS
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Phase 2 taVNS Tolerability survey
Time frame: Within 48 hours of completing Phase 2 taVNS
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
6 secondary outcomes
Phase 1 Blood Pressure Immediately before taVNS is applied
Time frame: Immediately before taVNS Phase 1 application is applied
Phase 1 Blood Pressure during taVNS application
Time frame: During taVNS Phase 1 application
Phase 1 Blood Pressure Immediately after taVNS is stopped
Time frame: Immediately after taVNS Phase 1 application is stopped
Phase 1 Blood Pressure 5 minutes after taVNS is stopped
Time frame: 5 minutes after taVNS Phase 1 application is stopped
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission
Time frame: Admission to rehabilitation
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge
Time frame: Immediately after discharge from rehabilitation
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 5 Aug 2026.
- Individual participant dataSharing planned: No. This is an internally funded study with limited personnel support. Adequate preparation of the data to ensure seamless and rigorous sharing cannot be guaranteed at the time of registration. The investigators may update the plan to share IPD in the future if additional personnel support becomes available.
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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.
Rachel E Cowan, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transauricular vagus nerve stimulation in people with Spinal Cord Injuries (Complete and Incomplete), run by University of Alabama at Birmingham at 1 site in United States.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 Aug 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Rachel E Cowan, PhD (2059345034, recowan@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Hypotension Symptoms Immediately before taVNS is applied (time frame: Immediately before Phase 1 taVNS application). The study lists 6 primary outcomes in all. 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 5 Aug 2026.