Spinal Cord Injury
Conditions
Brief summary
This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.
Detailed description
This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury. Neuromodulation will be in the form of transcutaneous electrical stimulation and/or magnetic stimulation.
Interventions
DEVICEElectromagnetic Neuromodulation
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Sponsors
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Male 18-45 years; 2. At least 1 year post-injury; 3. Non-progressive SCI at C2-T8 (non-conus injury); 4. Motor Complete ASIA (A or B); 5. Neurogenic bladder requiring clean intermittent straight catheterization; 6. Able to attend twice weekly testing sessions for 6 months. 7. Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping.
Exclusion criteria
1. History of autonomic dysreflexia; 2. Ventilator dependency; 3. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection; 4. Clinically significant depression or ongoing drug abuse; 5. Received botox injection, or bladder surgery (suprapubic access, Brindley procedure, etc.); 6. Prostatic hypertrophy or bladder outlet disorder; 7\. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine flow and volume | Months 1-48 |
Countries
United States
Contacts
CONTACTDaniel Lu, MD PhD
Outcome results
None listed