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NCT02331979NARecruiting

Improving Bladder Function in SCI by Neuromodulation

University of California, Los Angeles

Start Date

9/1/2015

Completion Date

1/31/2027

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.

Eligibility Criteria

Age Range: 18 years to 45 years

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.

Interventions

DEVICE

Electromagnetic Neuromodulation

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Conditions

Spinal Cord Injury

Locations

University of California, Los Angeles

Los Angeles, California 90095

United States