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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
bilateral transauricular vagal nerve stimulation
University of Alabama at Birmingham
Birmingham, Alabama, United States
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Time frame: Immediately before Phase 1 taVNS application
Phase 1 Hypotension Symptoms during taVNS spplication
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Time frame: During application of Phase 1 taVNS
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Time frame: Immediately after Phase 1 taVNS is stopped
Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Time frame: 5 minutes after Phase 1 taVNS is stopped
Phase 1 taVNS Tolerability survey
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Time frame: Within 48 hours of competing Phase 1 taVNS
Phase 2 taVNS Tolerability survey
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Time frame: Within 48 hours of completing Phase 2 taVNS
Phase 1 Blood Pressure Immediately before taVNS is applied
Systolic and Diastolic Blood Pressure (mmHg)
Time frame: Immediately before taVNS Phase 1 application is applied
Phase 1 Blood Pressure during taVNS application
Systolic and Diastolic Blood Pressure (mmHg)
Time frame: During taVNS Phase 1 application
Phase 1 Blood Pressure Immediately after taVNS is stopped
Systolic and Diastolic Blood Pressure (mmHg)
Time frame: Immediately after taVNS Phase 1 application is stopped
Phase 1 Blood Pressure 5 minutes after taVNS is stopped
Systolic and Diastolic Blood Pressure (mmHg)
Time frame: 5 minutes after taVNS Phase 1 application is stopped
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission
Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record
Time frame: Admission to rehabilitation
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge
Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record
Time frame: Immediately after discharge from rehabilitation
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