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Behavioural Intervention

Spinal Stimulation + Buspirone for Paralysis

Phase < 1

Waitlist Available

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking anti-spasticity medications

Neurological level of injury below T1 and above T8

Must not have

Untreated active urinary tract infections

Lower extremity lower motor neuron injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after each study phase, 1 year per group.

Awards & highlights

No Placebo-Only Group

Summary

This trial will be testing the combination of noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in order to help facilitate locomotor activity in people with paralysis due to severe spinal cord injury. The goal is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants who are at least one year post-injury.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include discomfort from the stimulation device; reactions to buspirone such as dizziness, nausea or headaches; muscle fatigue during physical training; skin irritation from equipment use; and potential interaction effects if other medications are taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on any medication for muscle stiffness.

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My spinal cord injury is between T1 and T8.

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

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My spinal cord injury is between T1 and T8.

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I am between 18 and 65 years old.

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

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I am between 18 and 65 years old.

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I am not taking any medication for muscle stiffness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an untreated urinary tract infection.

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I have nerve damage in my legs.

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

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I have nerve damage in my hands or feet.

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I have heart or lung disease not caused by my spinal cord injury.

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I have a bone fracture that hasn't healed.

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I have been diagnosed with osteoporosis.

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I have anemia.

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I have a metal implant in my leg.

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I experience pain in my muscles or joints.

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I have a seizure disorder.

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My liver function tests are abnormal.

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I have active pressure sores.

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I had leg injuries or disorders before or at the same time as my spinal injury.

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I have tightness in my legs that limits movement.

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I need help with daily activities and cannot stand on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after each study phase, 1 year per group.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after each study phase, 1 year per group.

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after each study phase, 1 year per group. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acoustic Gastro-Intestinal Surveillance, change over time

Assessment of verbal fluency, change over time

Bladder capacity, change over time

+13 more

Secondary study objectives

Ashworth Scale, change over time

International Standards of Neurological Classification of Spinal Cord Injury, change over time

Spinal Cord

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buspirone

2022

Completed Phase 4

~1160

Body Weight Supported Treadmill Training

2006

Completed Phase 2

~200

0 / 24Eligibility criteria met

Find a Location

Who is running the clinical trial?

The National Institute of Neurological Disorders and Stroke (NINDS)UNKNOWN

University of LouisvilleLead Sponsor

348 Previous Clinical Trials

77,686 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,381 Previous Clinical Trials

652,235 Total Patients Enrolled

Alexander V Ovechkin, PhD5.03 ReviewsStudy Director - University of Louisville

University of Louisville

5Patient Review

Dr. Afanasyev's bedside manner is top-notch. He took the time to ensure that we fully understood the situation and what the next steps were. We no longer have to rely on ibuprofen, thanks to him.