Auricular Vagus Nerve Stimulation (aVNS) in Chronic Spinal Cord Injuries (SCI)
NCT ID: NCT06588608
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2025-02-04
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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aVNS followed by no aVNS in subjects with SCI
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.
auricular nerve stimulation (aVNS)
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
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.
no aVNS followed by aVNS in subjects with SCI
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.
auricular nerve stimulation (aVNS)
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
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.
Interventions
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auricular nerve stimulation (aVNS)
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
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
4. Previous bariatric surgery
5. Active implantable devices (such as pacemakers)
6. Skin irritation or damage at the site (ear)
Exclusion Criteria
2. Prisoner
18 Years
65 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of Miami
OTHER
Responsible Party
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Patrick Daniel Ganzer
Assistant Professor
Principal Investigators
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Patrick D Ganzer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20240490
Identifier Type: -
Identifier Source: org_study_id
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