Spinal Cord InjuriesEarly Phase 1NCT04105114
Transformation of Paralysis to Stepping
A Early Phase 1 study testing Buspirone, Non-invasive Spinal Cord Stimulation and Overground stepping in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Buspirone, Non-invasive Spinal Cord Stimulation and Overground stepping
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, 40202
About this study
Official title: Transformation of Paraplegic Paralysis to Overground Stepping in Humans
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Buspirone, Non-invasive Spinal Cord Stimulation, Overground stepping, Gravity Neutral Device, Body Weight Supported Treadmill Training
- Keywords
- Walking, Transcutaneous Stimulation, Locomotion, Paralysis, Buspirone, Motor Control, Spinal Stimulation
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
Also called Buspar
Oral Buspirone 7.5mg - 10mg daily during the treatment phase.
Non-invasive Spinal Cord StimulationDevice
A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.
Overground steppingDevice
This intervention is designed to assist people with neurological injuries for balance, standing, and stepping overground.
Gravity Neutral DeviceDevice
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 TrainingDevice
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 WalkerDevice
A standard rolling walker will be used for balance support and stability during stepping overground.
| Study group | Role | What they receive |
|---|---|---|
| Complete Spinal Cord Injury - Gravity Neutral Stepping | Experimental | 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. Receives: Drug: Buspirone; Device: Non-invasive Spinal Cord Stimulation; Device: Gravity Neutral Device; Device: Body Weight Supported Treadmill Training |
| Complete Spinal Cord Injury - Overground Stepping | Experimental | 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. Receives: Drug: Buspirone; Device: Non-invasive Spinal Cord Stimulation; Device: Overground stepping; Device: Rolling Walker |
| Incomplete Spinal Cord Injury - Overground Stepping | Experimental | 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. Receives: Drug: Buspirone; Device: Non-invasive Spinal Cord Stimulation; Device: Overground stepping; Device: Rolling Walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Electromyography, change over time
Assessment of muscle activity, measured by electromyography, while the leg is suspended in a gravity neutral position.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after each study phase, 1 year per group.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after each study phase, 1 year per group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start30 Sep 2019
- Primary completion31 Aug 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a double blinded crossover study with three experimental groups. Each group will receive a combination of activity based neuromodulation interventions while receiving oral Buspirone or placebo. The crossover between drug or placebo administration will occur at the study phase midpoint.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Alexander V Ovechkin, MD, PhD, University of Louisville
- Investigators
- Alexander V Ovechkin, PhD, Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105114
- Sponsor's protocol ID
- 19.0434
- Other IDs
- 1R01NS102920-01A1
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transformation of Paraplegic Paralysis to Overground Stepping in Humans
- ClinicalTrials.gov ID
- NCT04105114
- Acronym / sponsor ID
- 19.0434
- Conditions
- Spinal Cord Injuries
- Keywords
- Walking, Transcutaneous Stimulation, Locomotion, Paralysis, Buspirone, Motor Control, Spinal Stimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a double blinded crossover study with three experimental groups. Each group will receive a combination of activity based neuromodulation interventions while receiving oral Buspirone or placebo. The crossover between drug or placebo administration will occur at the study phase midpoint.
| Arm | Type | Receives |
|---|---|---|
| Complete Spinal Cord Injury - Gravity Neutral Stepping | Experimental | Drug: Buspirone, Device: Non-invasive Spinal Cord Stimulation, Device: Gravity Neutral Device, Device: Body Weight Supported Treadmill TrainingGroup 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. |
| Complete Spinal Cord Injury - Overground Stepping | Experimental | Drug: Buspirone, Device: Non-invasive Spinal Cord Stimulation, Device: Overground stepping, Device: Rolling WalkerGroup 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. |
| Incomplete Spinal Cord Injury - Overground Stepping | Experimental | Drug: Buspirone, Device: Non-invasive Spinal Cord Stimulation, Device: Overground stepping, Device: Rolling WalkerGroup 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants with Motor Complete SCI:
- Participants with Motor Incomplete SCI:
Key exclusion criteria (15 listed)
- Untreated pressure sores,
- Unhealed bone fractures,
- Untreated active urinary tract infections,
- Peripheral lower limb neuropathies unrelated to SCI,
- Seizure disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuspironeAlso: BusparOral Buspirone 7.5mg - 10mg daily during the treatment phase. | Drug | Complete Spinal Cord Injury - Gravity Neutral Stepping, Complete Spinal Cord Injury - Overground Stepping, Incomplete Spinal Cord Injury - Overground Stepping |
| Non-invasive Spinal Cord StimulationA non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations. | Device | Complete Spinal Cord Injury - Gravity Neutral Stepping, Complete Spinal Cord Injury - Overground Stepping, Incomplete Spinal Cord Injury - Overground Stepping |
| Overground steppingThis intervention is designed to assist people with neurological injuries for balance, standing, and stepping overground. | Device | Complete Spinal Cord Injury - Overground Stepping, Incomplete Spinal Cord Injury - Overground Stepping |
| Gravity Neutral DeviceThis 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. | Device | Complete Spinal Cord Injury - Gravity Neutral Stepping |
| Body Weight Supported Treadmill TrainingParticipants 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. | Device | Complete Spinal Cord Injury - Gravity Neutral Stepping |
| Rolling WalkerA standard rolling walker will be used for balance support and stability during stepping overground. | Device | Complete Spinal Cord Injury - Overground Stepping, Incomplete Spinal Cord Injury - Overground Stepping |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
International Standards of Neurological Classification of Spinal Cord Injury, change over time
Time frame: Before and after each study phase, 1 year per group.
Spinal Cord Injury Functional Ambulation Inventory, change over time
Time frame: Before and after each study phase, 1 year per group.
Spinal Cord Independence Measure III, change over time
Time frame: Before and after each study phase, 1 year per group.
Walking Index for Spinal Cord Injury-II, change over time
Time frame: Before and after each study phase, 1 year per group.
Ashworth Scale, change over time
Time frame: Before and after each study phase, 1 year per group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander V Ovechkin, PhD study director
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Buspirone, Non-invasive Spinal Cord Stimulation and Overground stepping in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Electromyography, change over time (time frame: Before and after each study phase, 1 year per group.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.