- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105114
Transformation of Paralysis to Stepping
Transformation of Paraplegic Paralysis to Overground Stepping in Humans
Study Overview
Status
Conditions
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 Ekso-technology 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 Ekso-technology 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 Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Andrea Willhite, MS
- Phone Number: 502-582-8675
- Email: andrea.willhite@louisville.edu
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40202
- Recruiting
- Frazier Rehabilitation and Neuroscience Institute
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Contact:
- Andrea Willhite, MS
- Phone Number: 502-582-8675
- Email: andrea.willhite@louisville.edu
-
Sub-Investigator:
- Alexander V Ovechkin, MD, PhD
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Principal Investigator:
- Yury P Gerasimenko, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 18-65 years old;
- Stable medical condition;
- More than 12 month's post injury;
- Non-progressive spinal cord injury, AIS grade of A, B or C;
- Neurological level of injury below T1 and above T8;
- Not taking anti-spasticity medications;
- Presence of active spinally evoked responses over the lumbo-sacral spinal cord using spinal stimulation;
- Discontinuation of monoamine oxidase inhibitor (if applicable) for at least 2 weeks prior to initiation of treatment with buspirone.
Exclusion Criteria:
- Active pressure sores;
- Unhealed bone fractures;
- Untreated active urinary tract infections;
- Peripheral neuropathies;
- Seizure disorders;
- Cardiopulmonary disease unrelated to spinal cord injury;
- Anemia;
- Painful musculoskeletal dysfunction;
- Contractures in the lower extremities;
- Lower extremity hardware implantation;
- Lower extremity lower motor neuron injury;
- Previous unhealed lower extremity musculoskeletal injuries or disorders, prior to or in conjunction with spinal cord injury;
- Ventilator dependency;
- Pregnancy or nursing;
- Healing wounds/surgical sites along the spine, levels T9-L5;
- Anti-spasticity implantable pumps;
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse;
- Implantable suprapubic catheters;
- Individuals who are unable to support themselves and/or have difficulty standing;
- Individuals with abnormal blood panel results related to hepatic function. Up to 10 ml of venous blood will be obtained for the testing;
- Individuals with increased Creatinine Clearance (Clcr) levels above the normal range;
- Individuals who are taking drug(s) that interact(s) with Buspirone (BuSpar): Monoamine oxidase inhibitors (MAOIs) - Selegiline (Emsam), Isocarboxazid (Marplan), Phenelzine (Nardil), and Tranylcypromine (Parnate) /these medications must discontinue for at least 2 weeks prior to initiating treatment with Buspirone/; Selective serotonin reuptake inhibitors (SSRIs) - Nefazodone (Serzone) and Trazodone (Oleptro); the blood thinner - Warfarin (Coumadin); Unti-seizure drugs: Phenytoin (Dilantin) and Carbamazepine (Tegretol); Benzodiazepines - Diazepam (Valium) and Triazolam (Halcion); Muscle relaxant - Cyclobenzaprine (Flexeril); Anti-fungal drugs - Itraconazole (Sporanox, Onmel), Itraconazole (Sporanox), and Ketoconazole (Nizoral); Antibiotics - Erythromycin (E.E.S., E-Mycin, Erythrocin) and Rifampin (Rifadin, Rimactane); Steroids (Prednisone and others); Anti-HIV drug - Ritonavir (Norvir); Anti-hypertensive drugs - Diltiazem (Cardizem) and Verapamil (Calan, Verelan, Covera-HS); Anti-psychotic drug - Haloperidol (Haldol);
- Uncontrolled autonomic dysreflexia;
- Osteoporosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Complete Spinal Cord Injury - Gravity Neutral Stepping
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.
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Oral Buspirone 7.5mg - 10mg daily during the treatment phase.
Other Names:
A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.
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.
|
Experimental: Complete Spinal Cord Injury - Exoskeleton Assisted Stepping
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.
|
Oral Buspirone 7.5mg - 10mg daily during the treatment phase.
Other Names:
A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.
This robotic exoskeleton is designed to assist people with neurological injuries for balance, standing, and stepping overground.
A standard rolling walker will be used for balance support and stability during stepping overground.
|
Experimental: Incomplete Spinal Cord Injury - Overground Stepping
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.
|
Oral Buspirone 7.5mg - 10mg daily during the treatment phase.
Other Names:
A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.
This robotic exoskeleton is designed to assist people with neurological injuries for balance, standing, and stepping overground.
A standard rolling walker will be used for balance support and stability during stepping overground.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower Extremity Electromyography, change over time
Time Frame: Before and after each study phase, 1 year per group.
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Assessment of muscle activity, measured by electromyography, while the leg is suspended in a gravity neutral position.
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Before and after each study phase, 1 year per group.
|
Lower Extremity Kinematics, change over time
Time Frame: Before and after each study phase, 1 year per group.
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Assessment of low extremity 3D position, measured by motion analysis system, while the leg is suspended in a gravity neutral position.
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Before and after each study phase, 1 year per group.
|
Treadmill Electromyography Assessment, change over time
Time Frame: Before and after each study phase, 1 year per group.
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Muscle activity, measured by electromyography, will be recorded during weight supported stepping on a treadmill.
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Before and after each study phase, 1 year per group.
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Spinal Pathway Electrophysiology, change over time
Time Frame: Before and after each study phase, 1 year per group.
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Evoked potentials in the lower extremities will recorded in response to nerve or spinal stimulation.
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Before and after each study phase, 1 year per group.
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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.
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Before and after each study phase, 1 year per group.
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Voluntary Lower Extremity Forces, change over time
Time Frame: Before and after each study phase, 1 year per group.
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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.
|
Before and after each study phase, 1 year per group.
|
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.
|
Before and after each study phase, 1 year per group.
|
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.
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Before and after each study phase, 1 year per group.
|
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.
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Before and after each study phase, 1 year per group.
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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.
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Before and after each study phase, 1 year per group.
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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.
|
Before and after each study phase, 1 year per group.
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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.
|
Before and after each study phase, 1 year per group.
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Bladder capacity, change over time
Time Frame: Before and after each study phase, 1 year per group.
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We will use a standard technique to measure bladder volume change during voiding.
|
Before and after each study phase, 1 year per group.
|
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.
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Before and after each study phase, 1 year per group.
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Cognitive interference, change over time
Time Frame: Before and after each study phase, 1 year per group.
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A cognitive assessment using Stroop test will be administered to assess cognitive function during stress.
|
Before and after each study phase, 1 year per group.
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Assessment of verbal fluency, change over time
Time Frame: Before and after each study phase, 1 year per group.
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Controlled Oral Word Association Test (COWAT) will be administered to assess verbal fluency that measures ability of spontaneous production of words.
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Before and after each study phase, 1 year per group.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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.
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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.
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Before and after each study phase, 1 year per group.
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Spinal Cord Independence Measure III, change over time
Time Frame: Before and after each study phase, 1 year per group.
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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.
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Before and after each study phase, 1 year per group.
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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.
|
Before and after each study phase, 1 year per group.
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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.
|
Before and after each study phase, 1 year per group.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alexander V Ovechkin, PhD, University of Louisville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Paralysis
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Receptor Agonists
- Anti-Anxiety Agents
- Buspirone
Other Study ID Numbers
- 19.0434
- 1R01NS102920-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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