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Improving Bladder Function in SCI by Neuromodulation

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ClinicalTrials.gov Identifier: NCT02331979
Recruitment Status : Unknown
Verified January 2016 by Daniel Lu MD PhD, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Lu MD PhD, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE January 3, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2015)
Urine flow and volume [ Time Frame: Months 1-48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02331979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Bladder Function in SCI by Neuromodulation
Official Title  ICMJE Improving Bladder Function in SCI by Neuromodulation
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 Type  ICMJE Interventional
Study Phase Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Device: Electromagnetic Neuromodulation
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Other Names:
  • Transcutaneous Electrical Stimulation
  • Magnetic Stimulation
Study Arms
  • Experimental: Stimulation of Non-Naive
    Evaluate neuromodulation in 6 subjects with prior motor training.
    Intervention: Device: Electromagnetic Neuromodulation
  • Experimental: Stimulation of Naive
    Evaluate neuromodulation in 6 naive subjects.
    Intervention: Device: Electromagnetic Neuromodulation
  • Experimental: Stimulation
    Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.
    Intervention: Device: Electromagnetic Neuromodulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 3, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02331979
Other Study ID Numbers  ICMJE 14-000932
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Daniel Lu MD PhD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Los Angeles
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP