Vagus Nerve Stimulation for Spinal Cord Injury

(PIVOTS-Rehab Trial)

Overseen By Christopher Williamson, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Alabama at Birmingham

Disqualifiers: Age >89, Pregnant, Implanted devices, Epilepsy, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Rachel E Cowan, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Inclusion Criteria

I finished phase I, want to join phase II, have doctor approval, and get gait training.

I am 18 or older with a spinal cord injury and am in my first rehab stay.

Exclusion Criteria

Phase 2: No exclusion criteria for those who meet inclusion criteria

I do not have any implanted devices, neurological diseases, or metal in my head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Participants wear the taVNS device once for a short period of time to measure heart rate and blood pressure changes and assess tolerability.

1 day

1 visit (in-person)

Phase 2

Participants wear the taVNS device for a short time before each mobility therapy session to measure heart rate and blood pressure changes and assess tolerability.

Duration of inpatient rehabilitation

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transauricular vagus nerve stimulation

How Is the Trial Designed?

Group I: taVNS application Experimental Treatment 1 Intervention

This is a single arm study with two Phases. In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists. All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+