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Completed

NCT Number: NCT06588608

Auricular Vagus Nerve Stimulation (aVNS) in Chronic Spinal Cord Injuries (SCI)

The purpose of this research is to test if Auricular Vagal Nerve Stimulation (aVNS) is safe in persons with spinal cord injury (SCI).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females
  • Chronic (equal or greater to 1 year) motor-complete and incomplete SCI Abbreviated Injury Scale (AIS) of A or B at the C5-T10 levels

Exclusion criteria

  • Pregnant or breastfeeding
  • Prisoner
  • Failure to satisfy inclusion criteria
  • Previous bariatric surgery
  • Active implantable devices (such as pacemakers)
  • Skin irritation or damage at the site (ear)

Treatment and study plan

auricular nerve stimulation (aVNS)

Device

The Spark Sparrow system stimulates the auricular branch of the Vagus nerve using a low-voltage electrical signal comprising a 1 Hz - 150 Hz biphasic square wave with a pulse width of 50s - 750s. Stimulation current is controlled with a maximum voltage of 95 V and 1-5 milliamperes (mA) output current. The device is positioned at the auricular branch of the Vagus nerve on the ear with the outer electrode in front of the ear and the inner electrode into the hollow area of the ear, just above the ear canal. Stimulation will occur for 30 minutes. Participation will last up to 2 weeks and requires 2 separate in-person visits. Each visit will be up to 3 hours.

sham aVNS

Device

The Spark Sparrow system device will be positioned at the auricular branch of the Vagus nerve on the ear with the outer electrode in front of the ear and the inner electrode into the hollow area of the ear, just above the ear canal. Subjects will wear the device for 30 minutes during which no stimulation will be emitted. Participation will last up to 2 weeks and requires 2 separate in-person visits. Each visit will be up to 3 hours.

Primary outcomes

  1. Number of Treatment-related Adverse Events (AEs)

    Time frame: Up to 2 weeks

    Safety will be reported as the number of treatment-related AEs assessed by study PI or physician

  2. Number of subjects that complete the study

    Time frame: Up to 2 weeks

    Safety will be determined by number of subjects that complete the two study, visits (in total, two weeks).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

A Pilot Study of Auricular Vagus Nerve Stimulation on Cardiovascular Biomarkers and Glycemic Homeostasis in Persons With Chronic Spinal Cord Injuries

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 28, 2026

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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