Spinal Stimulation + Buspirone for Paralysis

Overseen By Andrea Willhite, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Louisville

Must be taking: Monoaminergic agonists

Must not be taking: MAOIs, SSRIs, Benzodiazepines, others

Disqualifiers: Seizure disorders, Cardiopulmonary disease, others

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

Compensation: Varies

Number of Visits: 18

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help people with paralysis walk again. It combines noninvasive spinal stimulation with buspirone, an anti-anxiety medication, to determine if they enhance walking with devices like robotic exoskeletons and treadmills. The study includes different groups trying various methods to identify the most effective approach. It seeks participants who have had a spinal cord injury for over a year and are no longer on anti-spasticity medications. This trial may suit those who struggle with walking due to a severe spinal cord injury but have a stable condition. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in spinal cord injury recovery.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, if you are on monoamine oxidase inhibitors, you must stop them at least 2 weeks before starting buspirone. Other medications that interact with buspirone may also need to be discontinued.

What prior data suggests that these neuromodulatory techniques are safe for people with paralysis?

Research has shown that the treatments tested in this trial have a good safety record from previous studies. The exoskeleton, a wearable robotic device, has been studied for safety and ease of use. It assists people with spinal cord injuries in walking after extensive practice, and no major safety issues have been identified.

The gravity neutral device, which simulates walking, has also been deemed safe for people with spinal cord injuries. It is used in rehabilitation, and studies have not reported any significant safety concerns.

Non-invasive spinal cord stimulation uses electrical currents to help restore movement. Research indicates it is safe and can improve movement and function in people with spinal cord injuries.

Buspirone, a medication used in the trial, is known to be safe for treating anxiety. It does not cause dependency or withdrawal problems. When studied with other drugs, it has shown no major safety issues, only mild side effects like nausea.

Overall, past research has shown these treatments to be well-tolerated, indicating they are generally safe for people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the spinal stimulation and Buspirone combination for paralysis because it offers a novel approach compared to traditional therapies like physical rehabilitation alone. Unlike standard treatments that focus solely on physical therapy or medication, this method integrates advanced technologies such as robotic exoskeletons and gravity-neutral devices with spinal stimulation. This unique combination aims to optimize neural recovery by directly stimulating the spinal cord, potentially enhancing motor function recovery. Adding Buspirone, a medication known to impact serotonin receptors, might further boost the nervous system's responsiveness, offering a promising new avenue for people with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for paralysis?

Research has shown that robotic exoskeletons, which participants in this trial may use, can greatly improve walking in people with spinal cord injuries. One study found that training with these exoskeletons led to better mobility scores. Another group in this trial will use devices that simulate weightlessness, called gravity-neutral devices, which also appear promising as they help people with long-term paralysis control their muscles better. Non-invasive spinal cord stimulation, used across the various treatment arms in this trial, has effectively improved movement, with many participants experiencing significant benefits. The medication buspirone, which some participants may receive, has shown to aid motor function recovery when used with spinal stimulation. ^{4 6 7 8 9}

Who Is on the Research Team?

Alexander V Ovechkin, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants undergo a preparation phase with up to 12 sessions in the Ekso device or gravity neutral device to determine optimal stimulation parameters

3-4 months

Up to 12 sessions

Intervention Phase 1

Participants receive training sessions 3 days/week for approximately 2 hours in the presence of stimulation and Buspirone/placebo

Varies per group

3 visits per week

Intervention Phase 2

Continuation of training with the same procedures, with or without Buspirone/placebo

Varies per group

3 visits per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Assistive Robotic Exoskeleton
• Body Weight Supported Treadmill Training
• Buspirone
• Gravity Neutral Device
• Non-invasive Spinal Cord Stimulation
• Rolling Walker

Trial Overview

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.

How Is the Trial Designed?

Group I: Incomplete Spinal Cord Injury - Overground Stepping Experimental Treatment 4 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 Stepping Experimental Treatment 4 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 Stepping Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

The National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1

Recruited

20+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

A six-week body weight-support treadmill training (BWSTT) program significantly improved center-of-mass control in chronic incomplete spinal cord injury (iSCI) patients, as indicated by changes in the instrumented sway test results.

However, the BWSTT program did not lead to improvements in gait independence, as measured by the Walking Index Spinal Cord Injury (WISCI) II test scores, suggesting that while balance may improve, it does not necessarily translate to better walking ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of body weight-support treadmill training on postural sway and gait independence in patients with chronic spinal cord injury. Covarrubias-Escudero, F., Rivera-Lillo, G., Torres-Castro, R., et al.[2020]

In a six-week study involving 20 multiple sclerosis patients, robot-assisted body-weight-supported treadmill training significantly improved the torque of both hip and knee joint muscles, enhancing lower limb muscle power.

This training led to better walking ability for patients, allowing them to walk with less effort and reduced reliance on caregivers, suggesting its potential as an effective rehabilitation method for gait dysfunction in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Body-Weight-Supported Treadmill Training in Gait Impairment in Multiple Sclerosis Patients: A Pilot Study. Łyp, M., Stanisławska, I., Witek, B., et al.[2019]

In a study involving 11 patients with incomplete spinal cord injury, patient-cooperative robot-aided gait training led to greater kinematic variability and increased muscle activity compared to non-cooperative training, suggesting enhanced engagement during rehabilitation.

The patient-cooperative approach, which allowed for free timing of movements and individually adjusted support, resulted in a more active participation from patients, indicating it may be a more effective method for gait rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-cooperative control increases active participation of individuals with SCI during robot-aided gait training. Duschau-Wicke, A., Caprez, A., Riener, R.[2021]

Body weight supported treadmill training significantly improves walking cadence, speed, and endurance in individuals with incomplete spinal cord injuries compared to conventional training methods, based on a review of six clinical trials from 2007 to 2019.

While this training method enhances certain aspects of gait, improvements in balance, functionality, and muscle strength are not significantly better than those achieved through conventional rehabilitation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treadmill training with partial body weight support in subjects with incomplete spinal cord injury: a systematic review]. Escribano-Ardura, S., Cuesta-Gómez, A., Fernández-González, P., et al.[2021]

A study involving four men with motor-incomplete spinal cord injury showed that 12 weeks of body weight-supported treadmill training (BWSTT) led to changes in brain activity, indicating potential supraspinal reorganization.

fMRI results revealed increased activation in sensorimotor and cerebellar regions after BWSTT, suggesting that this rehabilitation strategy not only improves locomotion but also enhances brain function related to movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Winchester, P., McColl, R., Querry, R., et al.[2022]

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