Improving Bladder Function in SCI by Neuromodulation

University of California, Los Angeles1 site in 1 country24 target enrollmentSeptember 1, 2015

ConditionsSpinal Cord Injury

InterventionsElectromagnetic Neuromodulation

Overview

Phase: N/A
Intervention: Electromagnetic Neuromodulation
Conditions: Spinal Cord Injury
Sponsor: University of California, Los Angeles
Enrollment: 24
Locations: 1
Primary Endpoint: Urine flow and volume
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2015

End Date

January 31, 2027

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of California, Los Angeles

Responsible Party

Principal Investigator

Daniel Lu, MD, PhD

Associate Professor

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

•Male 18-45 years;
•At least 1 year post-injury;
•Non-progressive SCI at C2-T8 (non-conus injury);
•Motor Complete ASIA (A or B);
•Neurogenic bladder requiring clean intermittent straight catheterization;
•Able to attend twice weekly testing sessions for 6 months.
•Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping.

Exclusion Criteria

•History of autonomic dysreflexia;
•Ventilator dependency;
•Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection;
•Clinically significant depression or ongoing drug abuse;
•Received botox injection, or bladder surgery (suprapubic access, Brindley procedure, etc.);
•Prostatic hypertrophy or bladder outlet disorder;
•7\. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.