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

NCT06543277 | Recruiting FDA Device

• 1 other identifier: HSC-MS-24-0346
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI)

Keywords

spinal cord injury (SCI); upper arm rehabilitation

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (7)

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

  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)

  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)

  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

  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

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

Study Arms (1)

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

EXPERIMENTAL

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Interventions

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.

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Mission Connect: collaborator

Study Sites (2)

Neurorecovery Research Center, TIRR MHH

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Radha Korupolu

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radha Korupolu, MD

CONTACT

713-797-5233; Radha.Korupolu@uth.tmc.edu

Shrasti Lohiya

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)