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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
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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.

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

First Posted
January 3, 2015
Last Updated
May 17, 2023
Sponsor
University of California, Los Angeles
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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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