Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury

NCT05601661 | Completed FDA Device

• 1 other identifier: HSC-MS-22-0579
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and feasibility of pairing vagus nerve stimulation (VNS) with rehabilitation and to determine the efficacy of pairing VNS with rehabilitation.

Conditions

Cervical Spinal Cord Injury

Keywords

vagus nerve stimulation

Outcome Measures

Primary Outcomes (10)

• Safety as assessed by number of subjects with post surgical complications

  post-surgical complications include but are not limited to dysphagia, hematoma, hoarseness of voice, vocal cord paralysis, edema, pain, and post-surgical infection

  90-day follow-up

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

  pretreatment, post treatment (about 6 weeks after pre treatment )

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

  pretreatment, post treatment (about 6 weeks after pre treatment )

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

  pretreatment, post treatment (about 6 weeks after pre treatment )

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

  pretreatment, post treatment (about 6 weeks after pre treatment )

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

  pretreatment, post treatment (about 6 weeks after pre treatment )

• Safety as assessed by number of subjects with worsening spasticity

  pretreatment, post treatment (about 6 weeks after pre treatment )

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

  pretreatment, post treatment (about 6 weeks after pre treatment )

• Feasibility as assessed by the number of participants that completed all the sessions

  end of study(about 132 days after enrollment)

• Feasibility as assessed by the number of participants that dropped out of the study

  end of study(about 132 days after enrollment)

Secondary Outcomes (7)

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

  baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

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

  baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

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

  baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

• Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire

  baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

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

  baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

Study Arms (2)

Treatment group

EXPERIMENTAL

Participants in the treatment group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired VNS over six weeks. Followed by 90 days home exercise program.

Device: Active VNS; Other: Arm rehabilitation

Control Group

SHAM COMPARATOR

Participants in the control group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with sham VNS over six weeks. Followed by 90 days home exercise program.

Device: Sham VNS; Other: Arm rehabilitation

Interventions

Active VNS DEVICE

An implantable system consisting of an implantable neurostimulator (model 1001 Implantable Pulse Generator (IPG)) and an implantable lead and electrode (Model 30000 VNS lead) will be used. An external system consisting of an external controller (Model 2000 Wireless Transmitter) and an external software system (computer and Model 4001 Microtransponder SAPS® software) will provide clinical control of settings for the implantable pulse generator (IPG) . All VNS devices (Vivistim System® ) will be provided as a donation by Microtransponder Inc. The device is programmed to stimulate for 0.5s on each button push. After surgical recovery, participants will receive five stimulations in reducing strength (starting at 0.8mA and then reducing to 0.1mA each step) at the beginning of each therapy session, followed by stimulation (0.8 mA)

Treatment group

Sham VNS DEVICE

An implantable system consisting of an implantable neurostimulator (model 1001 Implantable Pulse Generator (IPG)) and an implantable lead and electrode (Model 30000 VNS lead) will be used. An external system consisting of an external controller (Model 2000 Wireless Transmitter) and an external software system (computer and Model 4001 Microtransponder SAPS® software) will provide clinical control of settings for the implantable pulse generator (IPG) . All VNS devices (Vivistim System® ) will be provided as a donation by Microtransponder Inc. The device is programmed to stimulate for 0.5s on each button push. After surgical recovery, participants will receive five stimulations in reducing strength (starting at 0.8mA and then reducing to 0.1mA each step) at the beginning of each therapy session, followed by stimulation (0 mA)

Control Group

Arm rehabilitation OTHER

. The rehabilitation therapy involves arm and hand exercises with objects. The therapist will select these exercises based on movement abilities. Tasks will be selected from six functional task categories: reach and grasp, gross movement, object flipping, simulated eating tasks, inserting objects, and opening containers. Approximately 30-50 repetitions will be performed in each category. On average, 300-500 repetitions will be performed during each session within 1.5-2hours.

Control Group; Treatment group

Eligibility Criteria

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

You may qualify if:

• a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
• at least 12 months post-traumatic SCI
• demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger)
• meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist.

You may not qualify if:

• non-traumatic SCI, injury
• presence of ongoing dysphasia or aspiration difficulties
• evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure
• participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon
• concomitant clinically significant brain injury
• history of prior injury to a vagus nerve
• receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
• other comorbidities or complications that will hinder or contraindicate surgical procedure
• 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
• MicroTransponder Inc.: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Yozbatiran N, Francisco GE, Korupolu R. Safety and feasibility of paired vagus nerve stimulation with rehabilitation for improving upper extremity function in people with cervical spinal cord injury: study protocol for a pilot randomized controlled trial. Front Neurol. 2024 Nov 14;15:1465764. doi: 10.3389/fneur.2024.1465764. eCollection 2024.

  PMID: 39610700 DERIVED

Study Officials

• Radha Korupolu

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 1, 2022
• Study Start: June 15, 2023
• Primary Completion: August 16, 2025
• Study Completion: August 16, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)