Improving Bladder Function in SCI by Neuromodulation
Primary Purpose
Spinal Cord Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electromagnetic Neuromodulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
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.); 6. Prostatic hypertrophy or bladder outlet disorder;
7. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.
Sites / Locations
- University of California, Los AngelesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Stimulation of Non-Naive
Stimulation of Naive
Stimulation
Arm Description
Evaluate neuromodulation in 6 subjects with prior motor training.
Evaluate neuromodulation in 6 naive subjects.
Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.
Outcomes
Primary Outcome Measures
Urine flow and volume
Secondary Outcome Measures
Full Information
NCT ID
NCT02331979
First Posted
January 3, 2015
Last Updated
May 17, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02331979
Brief Title
Improving Bladder Function in SCI by Neuromodulation
Official Title
Improving Bladder Function in SCI by Neuromodulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stimulation of Non-Naive
Arm Type
Experimental
Arm Description
Evaluate neuromodulation in 6 subjects with prior motor training.
Arm Title
Stimulation of Naive
Arm Type
Experimental
Arm Description
Evaluate neuromodulation in 6 naive subjects.
Arm Title
Stimulation
Arm Type
Experimental
Arm Description
Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.
Intervention Type
Device
Intervention Name(s)
Electromagnetic Neuromodulation
Other Intervention Name(s)
Transcutaneous Electrical Stimulation, Magnetic Stimulation
Intervention Description
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Primary Outcome Measure Information:
Title
Urine flow and volume
Time Frame
Months 1-48
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.); 6. Prostatic hypertrophy or bladder outlet disorder;
7. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Lu, MD PhD
Phone
310-825-4321
Email
dclu@mednet.ucla.edu
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel C Lu, MD PhD
Phone
310-267-2975
Email
dclu@mednet.ucla.edu
12. IPD Sharing Statement
Learn more about this trial
Improving Bladder Function in SCI by Neuromodulation
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