Spinal Cord Injuries (Complete and Incomplete)
Conditions
Keywords
vagus nerve stimulation, spinal cord injuries, Rehabilitation, walking
Brief 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.
Interventions
bilateral transauricular vagal nerve stimulation
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D) * Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan
Exclusion criteria
* Phase 1 Age \>89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants * Phase 2 no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Hypotension Symptoms Immediately before taVNS is applied | Immediately before Phase 1 taVNS application | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible |
| Phase 1 Hypotension Symptoms during taVNS spplication | During application of Phase 1 taVNS | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible |
| Phase 1 Hypotension Symptoms Immediately after taVNS is stopped | Immediately after Phase 1 taVNS is stopped | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible |
| Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped | 5 minutes after Phase 1 taVNS is stopped | Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible |
| Phase 1 taVNS Tolerability survey | Within 48 hours of competing Phase 1 taVNS | 10 question survey addressing perceived sensation, tolerability, side effects, and open text response |
| Phase 2 taVNS Tolerability survey | Within 48 hours of completing Phase 2 taVNS | 10 question survey addressing perceived sensation, tolerability, side effects, and open text response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Blood Pressure Immediately before taVNS is applied | Immediately before taVNS Phase 1 application is applied | Systolic and Diastolic Blood Pressure (mmHg) |
| Phase 1 Blood Pressure during taVNS application | During taVNS Phase 1 application | Systolic and Diastolic Blood Pressure (mmHg) |
| Phase 1 Blood Pressure Immediately after taVNS is stopped | Immediately after taVNS Phase 1 application is stopped | Systolic and Diastolic Blood Pressure (mmHg) |
| Phase 1 Blood Pressure 5 minutes after taVNS is stopped | 5 minutes after taVNS Phase 1 application is stopped | Systolic and Diastolic Blood Pressure (mmHg) |
| Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission | Admission to rehabilitation | Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record |
| Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge | Immediately after discharge from rehabilitation | Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record |
Countries
United States
Contacts
CONTACTRachel E Cowan, PhD
CONTACTChristopher Williamson, MBA
PRINCIPAL_INVESTIGATORRachel E Cowan, PhD
University of Alabama at Birmingham
Outcome results
None listed