Improving Bladder Function in SCI by Neuromodulation

Spinal Cord Injury Clinical Trial

Official title:

Improving Bladder Function in SCI by Neuromodulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331979
• Other study ID #: 14-000932
• Status: Recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: Daniel Lu, MD PhD
• Phone: 310-825-4321
• Email: dclu[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Electromagnetic Neuromodulation
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine flow and volume		Months 1-48