Status:
ACTIVE_NOT_RECRUITING
Transformation of Paralysis to Stepping
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
The National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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 effecti...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04105114
Start Date
September 30 2019
End Date
December 31 2027
Last Update
March 10 2025
Active Locations (1)
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1
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, United States, 40202