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

NCT06588608 | Recruiting FDA Device

• 1 other identifier: 20240490
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Number of Treatment-related Adverse Events (AEs)

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

  Up to 2 weeks

• Number of subjects that complete the study

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

  Up to 2 weeks

Study Arms (2)

aVNS followed by no aVNS in subjects with SCI

EXPERIMENTAL

Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. In the following visit, subjects will complete all study assessments without the aVNS. Participation will be up to 2 weeks.

Device: auricular nerve stimulation (aVNS); Device: sham aVNS

no aVNS followed by aVNS in subjects with SCI

EXPERIMENTAL

Subjects will complete all study assessments without the aVNS. In the following visit, Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. Participation will be up to 2 weeks.

Device: auricular nerve stimulation (aVNS); Device: sham aVNS

Interventions

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.

aVNS followed by no aVNS in subjects with SCI; no aVNS followed by aVNS in subjects with SCI

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.

aVNS followed by no aVNS in subjects with SCI; no aVNS followed by aVNS in subjects with SCI

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

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

• Patrick D Ganzer, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Graham, MS, CCRC

CONTACT

3052435110; pgraham1@med.miami.edu

Patrick D Ganzer, PhD

CONTACT

305-243-7112; pxg487@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)