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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Device: auricular nerve stimulation (aVNS); Device: sham aVNS

• Registration Number: NCT06588608
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Status Verified: 2024-12
• Study Start: 2025-02-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
aVNS followed by no aVNS in subjects with SCI	auricular nerve stimulation (aVNS)	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.
aVNS followed by no aVNS in subjects with SCI	sham aVNS	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.
no aVNS followed by aVNS in subjects with SCI	auricular nerve stimulation (aVNS)	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.
no aVNS followed by aVNS in subjects with SCI	sham aVNS	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.

Primary Outcome Measures

Name	Time	Method
Number of Treatment-related Adverse Events (AEs)	Up to 2 weeks	Safety will be reported as the number of treatment-related AEs assessed by study PI or physician
Number of subjects that complete the study	Up to 2 weeks	Safety will be determined by number of subjects that complete the two study, visits (in total, two weeks).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States