Improving Bladder Function in SCI by Neuromodulation

NCT02331979 | Recruiting DMC

• 1 other identifier: 14-000932
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Urine flow and volume

  Months 1-48

Study Arms (3)

Stimulation of Non-Naive

EXPERIMENTAL

Evaluate neuromodulation in 6 subjects with prior motor training.

Device: Electromagnetic Neuromodulation

Stimulation of Naive

EXPERIMENTAL

Evaluate neuromodulation in 6 naive subjects.

Device: Electromagnetic Neuromodulation

Stimulation

EXPERIMENTAL

Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.

Device: Electromagnetic Neuromodulation

Interventions

Electromagnetic Neuromodulation DEVICE

Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.

Also known as: Transcutaneous Electrical Stimulation, Magnetic Stimulation

Stimulation; Stimulation of Naive; Stimulation of Non-Naive

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.); 6. Prostatic hypertrophy or bladder outlet disorder;
• \. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Daniel Lu, MD PhD

CONTACT

310-825-4321; dclu@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2015
• First Posted: January 6, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)