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

Description

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

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Study Overview

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Study Details

Study overview

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.

Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury: A Pilot Randomized Control Trial.

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

Condition
Cervical Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Radha Korupolu, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2025-06-01