Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery
NCT07562113 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-22
Summary
This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).
This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.
This study has two main goals:
1. To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
2. To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.
This study has two parts.
In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.
In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.
Conditions
- Spinal Cord Injuries (Complete and Incomplete)
Interventions
- DEVICE
-
Transauricular vagus nerve stimulation
bilateral transauricular vagal nerve stimulation
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Rachel E Cowan, PhD · University of Alabama at Birmingham
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2027-12-15
- Completion
- 2027-12-15
Countries
- United States
Study Locations
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