AzTrials
AzTrials

Chronic Incomplete Cervical Spinal Cord Injury (SCI)NCT06543277

Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Chronic Incomplete Cervical Spinal Cord Injury (SCI), run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with upper-limb rehabilitation in adults with tetraplegia caused by cervical spinal cord injury. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
15 Aug 2025to 30 Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
  • at least 12 months post-traumatic SCI but less than 10 years post-SCI
  • demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger sufficient to grip small objects such as marble)

Who cannot join

  • non-traumatic SCI
  • recent ear trauma and skin lesions at the site of stimulation, such as sunburn, cuts, and open sores,
  • facial or ear pain,
  • allergic reaction to adhesives and electrodes,
  • any current or past history of cardiovascular disorders,
  • intracranial metal implants, pacemakers,
Show all 11Show fewer
  • concomitant clinically significant brain injury,
  • receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
  • If there is a plan for alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  • medical or mental instability;
  • pregnancy or plans to become pregnant during the study period

Trial locations and contacts

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

Radha Korupolu, MD contact

713-797-5233

Radha.Korupolu@uth.tmc.edu

Shrasti Lohiya contact

(713) 797-7132

Shrasti.Lohiya@uth.tmc.edu

United States2 sites, 2 recruiting

  • Neurorecovery Research Center, TIRR MHH

    Houston, Texas, 77030

    Alyssa Miller, BS, 7137977132, VNS.SCI@uth.tmc.edu

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Radha Korupolu, MD, 713-797-5233, Radha.Korupolu@uth.tmc.edu

    Shrasti Lohiya, (713) 797-7132, Shrasti.Lohiya@uth.tmc.edu

    Not yet recruiting

Other trials in United States

About this study

Official title: Safety and Feasibility of Paired taVNS With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with upper-limb rehabilitation in adults with tetraplegia caused by cervical spinal cord injury.

Being tested
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Keywords
spinal cord injury (SCI), upper arm rehabilitation
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.

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device

    Participants will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired taVNS over six weeks, followed by a 90-day home exercise program.

Study groups in NCT06543277
Study groupRoleWhat they receive
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)ExperimentalNot described
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

What is being measured

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

  1. Safety as assessed by number of subjects with change in systolic blood pressure

    Measured: Immediately after completing in-clinic 18 sessions (6-8 weeks)

  2. Safety as assessed by number of subjects with change in diastolic blood pressure

    Measured: Immediately after completing in-clinic 18 sessions (6-8 weeks)

  3. Safety as assessed by number of subjects with change in heart rate

    Measured: Immediately after completing in-clinic 18 sessions (6-8 weeks)

  4. Safety as assessed by number of subjects with change in respiratory rate

    Measured: Immediately after completing in-clinic 18 sessions (6-8 weeks)

  5. Safety as assessed by number of subjects with change in autonomic dysreflexia

    Measured: Immediately after completing in-clinic 18 sessions (6-8 weeks)

  6. Safety as assessed by number of subjects with worsening spasticity

    Measured: Immediately after completing in-clinic 18 sessions (6-8 weeks)

  7. Safety as assessed by number of subjects with change in pain at stimulation site

    Measured: Immediately after completing in-clinic 18 sessions (6-8 weeks)

  8. Safety as assessed by number of adverse events that occurred during the study period

    Measured: post therapy 30 days

  9. Feasibility as assessed by the number of treatment sessions attended by each participant . The intervention is considered feasible if at least 80% adherence rate is achieved and no serious adverse events occurred.

    80% adherence rate is defined as completing ≥ 16 out of 18 sessions

    Measured: from baseline through completion of 18 sessions (about 6-8 weeks)

  10. Feasibility as assessed by the participants' perceptions of the study procedures

    This includes implementation using the paired taVNS with rehabilitation. This is numerically rated from 'not difficult at all' at 0, and 'very difficult' at 10, higher score indicating worse outcome

    Measured: from baseline through completion of 18 sessions (about 6-8 weeks)

  11. Feasibility as assessed by the participants' perceptions of the usefulness of the intervention

    This is numerically rated from ''not at all useful' at 0 and 'very useful' at 10 , higher score indicating better outcome

    Measured: from baseline through completion of 18 sessions (about 6-8 weeks)

Secondary outcomes (7)

  1. Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assessment

    The 3 measured domains are as follows:

    1. Strength: Motor grading of 10 arm and hand muscles for right and left arm will be performed. Each muscle is graded from 0 to 5 for a maximum score of 50, a higher number indicating more strength.
    2. Dorsal and palmar sensation: Each test location is scored from 0 to 4. Three locations for the dorsal side of each hand and 3 for palmer location of each hand are summed to render a subtest total score between 0 and 12 a higher score indicating more sensation.
    3. Prehension:
    4. Qualitative prehension: The participant performs 3 tasks using each hand and is scored from 0-12 a higher number indicating a better outcome
    5. Quantitative prehension: he participant performs 6 tasks using each hand and is scored from 0-30 a higher number indicating a better outcome

    Measured: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

  2. Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT)

    This is a 14 item questionnaire and each is scored from 1(no movement elicited) to 8(normal grasp) a higher number indicating better hand function

    Measured: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

  3. Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q)

    This is a 17 item questionnaire and each is scored from 1(totally limited) to 7(not at all limited), a higher number indicating better outcome

    Measured: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

  4. Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore

    This is a 4 item questionnaire and each is scored from 0(need total assistance) to 3(completely independent), higher score indicating more independence.

    Measured: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

  5. Change in Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire

    This questionnaire has 3 parts:

    basic mobility: this is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating more mobility Fine Motor: This is a 9 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome self care: This is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome

    Measured: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

  6. Change in Pain as assessed by the International SCI pain basic data subset (version 2)

    This is an 6 item questionnaire and each is scored from 0 (no pain) -10 (pain as bad as you can imagine), a higher score indicating more pain.

    Measured: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

  7. Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8)

    This is an eight item questionnaire and each is scored from 0(not at all) to 3(nearly every day) a higher score indicating worse outcome

    Measured: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

Timeline

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

  1. First posted7 Aug 2024
  2. Study start15 Aug 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Dec 2027 (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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06543277
Sponsor's protocol ID
HSC-MS-24-0346
Status last verified
Sep 2025
First submitted
2 Aug 2024
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Chronic Incomplete Cervical Spinal Cord Injury (SCI), run by The University of Texas Health Science Center, Houston at 2 sites 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 3 inclusion and 11 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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 Radha Korupolu, MD (713-797-5233, Radha.Korupolu@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as assessed by number of subjects with change in systolic blood pressure (time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06543277.

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 19 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in