Improving Bladder Function in SCI by Neuromodulation

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury
• Interventions: Device: Electromagnetic Neuromodulation

• Registration Number: NCT02331979
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2015-01-03
• Study First Submitted QC: 2015-01-03
• Study First Posted: 2015-01-06
• Study Start: 2015-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 24

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.

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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;

6. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimulation of Non-Naive	Electromagnetic Neuromodulation	Evaluate neuromodulation in 6 subjects with prior motor training.
Stimulation	Electromagnetic Neuromodulation	Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.
Stimulation of Naive	Electromagnetic Neuromodulation	Evaluate neuromodulation in 6 naive subjects.

Primary Outcome Measures

Name	Time	Method
Urine flow and volume	Months 1-48

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States