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

University of Miami

Status: Enrolling

Conditions: Spinal Cord Injuries

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06588608

20240490

Details and patient eligibility

About

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

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females
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

Exclusion criteria

1. Pregnant or breastfeeding
2. Prisoner
3. Failure to satisfy inclusion criteria
4. Previous bariatric surgery
5. Active implantable devices (such as pacemakers)
6. Skin irritation or damage at the site (ear)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

aVNS followed by no aVNS in subjects with SCI

Experimental group

Description:

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.

Treatment:

Device: auricular nerve stimulation (aVNS)

Device: sham aVNS

no aVNS followed by aVNS in subjects with SCI

Experimental group

Description:

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.

Treatment:

Device: auricular nerve stimulation (aVNS)

Device: sham aVNS