Spinal Stimulation + Buspirone for Paralysis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Louisville

No Placebo Group

Trial Summary

What is the purpose of this trial?The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in facilitating locomotor activity in a gravity-neutral apparatus, during body weight supported stepping on a treadmill, when stepping overground in an assistive robotic exoskeleton, or during full weight bearing stepping overground in a rolling walker. Our objective is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants with severe spinal cord injury who are at least one year post-injury.

Eligibility Criteria

This trial is for adults aged 18-65 with stable spinal cord injuries (AIS grade A, B, or C) that occurred over a year ago. Participants must not be on anti-spasticity meds or MAO inhibitors and should have active responses in their lower spine to stimulation. Exclusions include those with certain health conditions like unhealed fractures, infections, severe diseases unrelated to the injury, pregnancy, drug abuse issues, and some medication interactions.

Inclusion Criteria

I am not on any medication for muscle stiffness.

My spinal cord injury is between T1 and T8.

My spinal cord injury is stable and classified as A, B, or C.

+11 more

Exclusion Criteria

I currently have an untreated urinary tract infection.

I have nerve damage in my legs.

I am healing from spine surgery between my mid-back and lower back.

+21 more

Participant Groups

The study tests if non-invasive spinal stimulation combined with buspirone can help people with paralysis step using different supports: gravity-neutral devices, treadmills with body support, robotic exoskeletons by Ekso Bionics or rolling walkers. It's a five-year study involving 15 participants to find out which techniques work best.

3Treatment groups

Experimental Treatment

Group I: Incomplete Spinal Cord Injury - Overground SteppingExperimental Treatment4 Interventions

Group 3 will begin with a 3-month preparation phase and up to 12 sessions in the Ekso device stepping overground. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours. The first hour will be done in the Ekso overground and the second hour will use the rolling walker overground, both in the presence of stimulation. Afterwards, the second phase will include the same training procedures with the addition of Buspirone/placebo.

Group II: Complete Spinal Cord Injury - Gravity Neutral SteppingExperimental Treatment4 Interventions

Group 1 will begin with a 3-4-month preparation phase and up to 12 sessions in the gravity neutral device (GND) will occur. The training sessions in the GND will be used to obtain the optimal stimulation parameters. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours. This will be done in the GND in the presence of stimulation. Afterwards, Intervention 2 will include the same training procedures with the addition of Buspirone or Placebo in a cross-over fashion halfway through this phase.

Group III: Complete Spinal Cord Injury - Exoskeleton Assisted SteppingExperimental Treatment4 Interventions

Group 2 will begin with a 3-month preparation phase and up to 12 sessions in the Ekso device stepping overground. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours in the Ekso overground, in the presence of stimulation and Buspirone/placebo. The second phase will include the same training procedures except for the removal of Buspirone/placebo administration. The third phase will include sessions twice per week in the Ekso overground with stimulation and one day per week using a rolling walker with stimulation. The last phase will include 2 sessions per week using the rolling walker and one day per week in the Ekso, both in the presence of stimulation and Buspirone/placebo.