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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Timeframe: Immediately before Phase 1 taVNS application
Phase 1 Hypotension Symptoms during taVNS spplication
Timeframe: During application of Phase 1 taVNS
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
Timeframe: Immediately after Phase 1 taVNS is stopped
Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
Timeframe: 5 minutes after Phase 1 taVNS is stopped
Phase 1 taVNS Tolerability survey
Timeframe: Within 48 hours of competing Phase 1 taVNS
Phase 2 taVNS Tolerability survey
Timeframe: Within 48 hours of completing Phase 2 taVNS