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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Incomplete Cervical Spinal Cord Injury (SCI)
• Intervention / Treatment: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radha Korupolu, MD; Phone Number: 713-797-5233; Email: Radha.Korupolu@uth.tmc.edu
• Study Contact Backup: Name: Shrasti Lohiya; Phone Number: (713) 797-7132; Email: Shrasti.Lohiya@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Radha Korupolu, MD; Phone Number: 713-797-5233; Email: Radha.Korupolu@uth.tmc.edu
      • Contact: Shrasti Lohiya; Phone Number: (713) 797-7132; Email: Shrasti.Lohiya@uth.tmc.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • Neurorecovery Research Center, TIRR MHH
      • Contact: Alyssa Miller, BS; Phone Number: 7137977132; Email: VNS.SCI@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)	Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by number of subjects with change in systolic blood pressure		Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in diastolic blood pressure		Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in heart rate		Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in respiratory rate		Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in autonomic dysreflexia		Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with worsening spasticity		Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of subjects with change in pain at stimulation site		Immediately after completing in-clinic 18 sessions (6-8 weeks)
Safety as assessed by number of adverse events that occurred during the study period		post therapy 30 days
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	from baseline through completion of 18 sessions (about 6-8 weeks)
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	from baseline through completion of 18 sessions (about 6-8 weeks)
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	from baseline through completion of 18 sessions (about 6-8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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 outcomeQuantitative prehension: he participant performs 6 tasks using each hand and is scored from 0-30 a higher number indicating a better outcome	Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]
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	Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]
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	Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]
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.	Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]
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	Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]
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.	Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]
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	Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Mission Connect
• Investigators: Principal Investigator: Radha Korupolu, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: spinal cord injury (SCI); upper arm rehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: HSC-MS-24-0346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No