Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 exclusion criteria for those who meet inclusion criteria
Trial design
Design model
Single group
Treatments tested in this trial
Transauricular vagus nerve stimulation
Devicebilateral transauricular vagal nerve stimulation
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: taVNS applicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 application2
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 taVNS3
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 stopped4
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 stoppedSecondary outcomes
1
Phase 1 Blood Pressure Immediately before taVNS is applied
Systolic and Diastolic Blood Pressure (mmHg)
Time frame
Immediately before taVNS Phase 1 application is applied2
Phase 1 Blood Pressure during taVNS application
Systolic and Diastolic Blood Pressure (mmHg)
Time frame
During taVNS Phase 1 application3
Phase 1 Blood Pressure Immediately after taVNS is stopped
Systolic and Diastolic Blood Pressure (mmHg)
Time frame
Immediately after taVNS Phase 1 application is stopped4
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 stoppedSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: