Clinical Trial

Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery

Study acronym: PIVOTS-Rehab
Not Yet Recruiting Phase 1/2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-24.
Trial Details
NCT Number NCT07562113
Lead Sponsor University of Alabama at Birmingham
Conditions Spinal Cord Injuries (Complete and Incomplete)
Enrollment 50 participants
Start Date 2026-11-01
Primary Completion 2027-12-15 (estimated)
Study Completion 2027-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-05