An Early Phase 1 interventional study of Buspirone and Non-invasive Spinal Cord Stimulation in Spinal Cord Injuries, sponsored by University of Louisville. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by University of Louisville · Early Phase 1, Interventional, and Basic science
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 15 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with Motor Complete SCI:
Participants with Motor Incomplete SCI:
Exclusion Criteria:
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.
Drug: Buspirone · Device: Non-invasive Spinal Cord Stimulation · Device: Gravity Neutral Device · Device: Body Weight Supported Treadmill Training
Group 2 will begin with a 3-month preparation phase and up to 12 sessions of overground stepping. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours overground training, 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 of the 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 in the presence of stimulation and Buspirone/placebo.
Drug: Buspirone · Device: Non-invasive Spinal Cord Stimulation · Device: Overground stepping · Device: Rolling Walker
Group 3 will begin with a 3-month preparation phase and up to 12 sessions stepping overground. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours. The overground session will use the rolling walker in the presence of stimulation. Afterwards, the second phase will include the same training procedures with the addition of Buspirone/placebo.
Drug: Buspirone · Device: Non-invasive Spinal Cord Stimulation · Device: Overground stepping · Device: Rolling Walker
Oral Buspirone 7.5mg - 10mg daily during the treatment phase.
Also known as: Buspar
A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.
This intervention is designed to assist people with neurological injuries for balance, standing, and stepping overground.
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.
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.
A standard rolling walker will be used for balance support and stability during stepping overground.
Lower Extremity Electromyography, change over time
Assessment of muscle activity, measured by electromyography, while the leg is suspended in a gravity neutral position.
Time frame: Before and after each study phase, 1 year per group.
Lower Extremity Kinematics, change over time
Assessment of low extremity 3D position, measured by motion analysis system, while the leg is suspended in a gravity neutral position.
Time frame: Before and after each study phase, 1 year per group.
Treadmill Electromyography Assessment, change over time
Muscle activity, measured by electromyography, will be recorded during weight supported stepping on a treadmill.
Time frame: Before and after each study phase, 1 year per group.
Spinal Pathway Electrophysiology, change over time
Evoked potentials in the lower extremities will recorded in response to nerve or spinal stimulation.
Time frame: Before and after each study phase, 1 year per group.
Voluntary Lower Extremity Angles, change over time
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.
Time frame: Before and after each study phase, 1 year per group.
Voluntary Lower Extremity Forces, change over time
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.
Time frame: Before and after each study phase, 1 year per group.
Body Temperature, change over time
We will measure body temperature using standard methods to assess values at rest and during exercise.
Time frame: Before and after each study phase, 1 year per group.
Blood Pressure, change over time
We will measure blood pressure (systolic and diastolic) using standard methods to assess values at rest and during exercise.
Time frame: Before and after each study phase, 1 year per group.
Heart Rate, change over time
We will measure the heart rate using standard electrocardiography to assess values at rest and during exercise.
Time frame: Before and after each study phase, 1 year per group.
Respiration Rate, change over time
We will measure respiratory rate using standard methods to assess values at rest and during exercise.
Time frame: Before and after each study phase, 1 year per group.
Dual-energy X-ray absorptiometry, change over time
We will use dual-energy X-ray absorptiometry to measure bone and soft tissue density.
Time frame: Before and after each study phase, 1 year per group.
Acoustic Gastro-Intestinal Surveillance, change over time
We will use non-invasive sensors placed on the abdomen to detect signals related to the digestive state.
Time frame: Before and after each study phase, 1 year per group.
Bladder capacity, change over time
We will use a standard technique to measure bladder volume change during voiding.
Time frame: Before and after each study phase, 1 year per group.
Urodynamics, change over time
We will use a standard technique to measure the abdominal pressure change during voiding.
Time frame: Before and after each study phase, 1 year per group.
Cognitive interference, change over time
A cognitive assessment using Stroop test will be administered to assess cognitive function during stress.
Time frame: Before and after each study phase, 1 year per group.
Assessment of verbal fluency, change over time
Controlled Oral Word Association Test (COWAT) will be administered to assess verbal fluency that measures ability of spontaneous production of words.
Time frame: Before and after each study phase, 1 year per group.
International Standards of Neurological Classification of Spinal Cord Injury, change over time
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.
Time frame: Before and after each study phase, 1 year per group.
Spinal Cord Injury Functional Ambulation Inventory, change over time
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.
Time frame: Before and after each study phase, 1 year per group.
Spinal Cord Independence Measure III, change over time
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.
Time frame: Before and after each study phase, 1 year per group.
Walking Index for Spinal Cord Injury-II, change over time
This is a 20-point scale used to assess the amount of physical assistance needed during walking.
Time frame: Before and after each study phase, 1 year per group.
Ashworth Scale, change over time
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.
Time frame: Before and after each study phase, 1 year per group.
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