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Active, Not Recruiting

NCT Number: NCT04105114

Transformation of Paralysis to Stepping

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, 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Frazier Rehabilitation and Neuroscience Institute

Louisville, Kentucky, 40202, United States

About this study

Aim 1: Define the relative effectiveness of transcutaneous electrical stimulation at multiple stimulation spinal sites and oral Buspirone in facilitating nonweight-bearing (gravity neutral device, GND) and weight-bearing (treadmill) stepping in individuals with chronic motor complete paralysis.

Aim 1.1: Define the relative effectiveness of transcutaneous electrical stimulation at multiple spinal sites to facilitate non-weight-bearing (GND) and weight-bearing (treadmill) stepping in spinal cord injury subjects.

Aim 1.2: Define the relative effectiveness of transcutaneous electrical stimulation at multiple spinal sites plus oral Buspirone to facilitate nonweight-bearing (gravity neutral device, GND) and weight-bearing (treadmill) stepping in spinal cord injury subjects.

Aim 2: Determine the relative effectiveness of overground LT combined with transcutaneous electrical stimulation and/or oral Buspirone in lowering the robotic assistance and enhancing the ability to step self-assisted in a rolling walker during over-ground stepping in individuals with a chronic, severe (AIS A/B) spinal injury.

Aim 3: Determine the relative effectiveness of overground LT combined with transcutaneous electrical stimulation and/or oral Buspirone in lowering the robotic assistance and enhancing the ability to step self-assisted in a rolling walker during over-ground stepping in individuals with motor incomplete (AIS C) paralysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

by study group:

  • Participants with Motor Complete SCI:
  • 18-65 years old,
  • Stable medical condition,
  • At least 1-year post-injury,
  • Non-progressive SCI,
  • Motor complete paraplegia: Unable to voluntarily move any joint of the lower limbs,
  • Inability to walk independently due to SCI,
  • Presence of active spinally evoked responses over the lumbo-sacral spinal cord using spinal Cord Transcutaneous Stimulation (scTS).
  • Participants with Motor Incomplete SCI:
  • 18-65 years old,
  • Stable medical condition,
  • At least 1-year post-injury,
  • Non-progressive SCI,
  • Motor incomplete paraplegia: Able to voluntarily move at least 1 joint of the lower limbs bilaterally,
  • Inability to walk independently in the community due to SCI,
  • Presence of active spinally evoked responses over the lumbo-sacral spinal cord using scTS.

Exclusion criteria

  • Untreated pressure sores,
  • Unhealed bone fractures,
  • Untreated active urinary tract infections,
  • Peripheral lower limb neuropathies unrelated to SCI,
  • Seizure disorders,
  • Cardiopulmonary disease unrelated to SCI,
  • Untreated anemia,
  • Ventilator dependency,
  • Female participants: Pregnant or planning to become pregnant during the time course of study, or nursing,
  • Healing wounds/surgical sites along the spine, levels T9-L5,
  • Anti-spasticity implantable pumps,
  • Untreated clinically significant depression, psychiatric disorders, or ongoing drug abuse,
  • Colostomy bag, urostomy,
  • Individuals with abnormal blood panel results related to hepatic function, Individuals with abnormal estimated glomerular filtration rate (eGFR) and increase Creatinine Clearance (CrCl) levels above the normal range,
  • Individuals unwilling or unable to wean from drug(s) that interact(s) with buspirone, such as: Monoamine oxidase inhibitors (MAOIs) - Selegiline (Emsam), Isocarboxazid (Marplan), Phenelzein (Nardil), and Tranylcypromine (Parnate).

Treatment and study plan

Buspirone

Drug

Oral Buspirone 7.5mg - 10mg daily during the treatment phase.

Other names: Buspar

Non-invasive Spinal Cord Stimulation

Device

A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.

Overground stepping

Device

This intervention is designed to assist people with neurological injuries for balance, standing, and stepping overground.

Gravity Neutral Device

Device

This device is used to train and assess non-weight bearing stepping movements. When using the device, participants will be lying on their side with their legs suspended off the end of a table supported by small slings that are anchored securely to the apparatus.

Body Weight Supported Treadmill Training

Device

Participants will be supported by a special harness while they are stepping on a treadmill. Trained technicians or therapists will be assist the trunk and legs during stepping as needed.

Rolling Walker

Device

A standard rolling walker will be used for balance support and stability during stepping overground.

Primary outcomes

  1. Lower Extremity Electromyography, change over time

    Time frame: Before and after each study phase, 1 year per group.

    Assessment of muscle activity, measured by electromyography, while the leg is suspended in a gravity neutral position.

  2. Lower Extremity Kinematics, change over time

    Time frame: Before and after each study phase, 1 year per group.

    Assessment of low extremity 3D position, measured by motion analysis system, while the leg is suspended in a gravity neutral position.

  3. Treadmill Electromyography Assessment, change over time

    Time frame: Before and after each study phase, 1 year per group.

    Muscle activity, measured by electromyography, will be recorded during weight supported stepping on a treadmill.

  4. Spinal Pathway Electrophysiology, change over time

    Time frame: Before and after each study phase, 1 year per group.

    Evoked potentials in the lower extremities will recorded in response to nerve or spinal stimulation.

  5. Voluntary Lower Extremity Angles, change over time

    Time frame: Before and after each study phase, 1 year per group.

    Assessments of knee, ankle, and toe movements will be performed by measuring angles produced during flexion and extension. The same units of measure will be used for each part of the leg.

  6. Voluntary Lower Extremity Forces, change over time

    Time frame: Before and after each study phase, 1 year per group.

    Assessments of knee, ankle, and toe forces during movements will be performed by measuring forces produced during flexion and extension. The same units of measure will be used for each part of the leg.

  7. Body Temperature, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will measure body temperature using standard methods to assess values at rest and during exercise.

  8. Blood Pressure, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will measure blood pressure (systolic and diastolic) using standard methods to assess values at rest and during exercise.

  9. Heart Rate, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will measure the heart rate using standard electrocardiography to assess values at rest and during exercise.

  10. Respiration Rate, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will measure respiratory rate using standard methods to assess values at rest and during exercise.

  11. Dual-energy X-ray absorptiometry, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will use dual-energy X-ray absorptiometry to measure bone and soft tissue density.

  12. Acoustic Gastro-Intestinal Surveillance, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will use non-invasive sensors placed on the abdomen to detect signals related to the digestive state.

  13. Bladder capacity, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will use a standard technique to measure bladder volume change during voiding.

  14. Urodynamics, change over time

    Time frame: Before and after each study phase, 1 year per group.

    We will use a standard technique to measure the abdominal pressure change during voiding.

  15. Cognitive interference, change over time

    Time frame: Before and after each study phase, 1 year per group.

    A cognitive assessment using Stroop test will be administered to assess cognitive function during stress.

  16. Assessment of verbal fluency, change over time

    Time frame: Before and after each study phase, 1 year per group.

    Controlled Oral Word Association Test (COWAT) will be administered to assess verbal fluency that measures ability of spontaneous production of words.

Secondary outcomes

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

    Time frame: Before and after each study phase, 1 year per group.

    This standard clinical assessment assess the level and severity of a spinal cord injury.

    The neurological level of injury is rated from A-E. "A" is a motor and sensory complete injury. "E" is completely normal at each spinal segment.

    Sensory function is rated as 0-2, or Not Testable. Motor function is rated as 0-5 or Not Testable.

  2. Spinal Cord Injury Functional Ambulation Inventory, change over time

    Time frame: Before and after each study phase, 1 year per group.

    This 3-part scale measures gait parameters, use of assistive devices, and distances traveled during walking. The gait parameters are scored on a 20-point scale, the assistive device use on a 14-point scale, and the walking distance on a 5-point scale.

  3. Spinal Cord Independence Measure III, change over time

    Time frame: Before and after each study phase, 1 year per group.

    This 3-part scale is scored out of 100 points possible. The first part (self-care) is scored out of 20. The second part (respiration and sphincter management) is scored out of 40. And the last part (mobility) is scored out of 40.

  4. Walking Index for Spinal Cord Injury-II, change over time

    Time frame: Before and after each study phase, 1 year per group.

    This is a 20-point scale used to assess the amount of physical assistance needed during walking.

  5. Ashworth Scale, change over time

    Time frame: Before and after each study phase, 1 year per group.

    This is a 6-part scale to measure and quantify the amount of muscle tone experienced when a joint is moved through a full range of motion.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)

Registry information

Official study title

Transformation of Paraplegic Paralysis to Overground Stepping in Humans

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Sep 26, 2019
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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