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NCT Number: NCT06543277

Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (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.

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Key information

Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurorecovery Research Center, TIRR MHH, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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,
  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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)

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

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

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

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

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

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

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

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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

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

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

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

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

    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

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

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

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

Secondary outcomes

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

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

    The 3 measured domains are as follows:

    • 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.
    • 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.
    • Prehension:
    • Qualitative prehension: The participant performs 3 tasks using each hand and is scored from 0-12 a higher number indicating a better outcome
    • Quantitative prehension: he participant performs 6 tasks using each hand and is scored from 0-30 a higher number indicating a better outcome

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

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

    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

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

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

    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

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

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

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

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

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

    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

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

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

    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.

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

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Radha Korupolu, MD

CONTACT

[email protected]

713-797-5233

Shrasti Lohiya

CONTACT

[email protected]

(713) 797-7132

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Mission Connect

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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