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Improving Bladder Function in SCI by Neuromodulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02331979
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Daniel Lu, MD, PhD, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Electromagnetic Neuromodulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Bladder Function in SCI by Neuromodulation
Study Start Date : September 2015
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stimulation of Non-Naive
Evaluate neuromodulation in 6 subjects with prior motor training.
 Device: Electromagnetic Neuromodulation
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Other Names:
  • Transcutaneous Electrical Stimulation
  • Magnetic Stimulation
Experimental: Stimulation of Naive
Evaluate neuromodulation in 6 naive subjects.
 Device: Electromagnetic Neuromodulation
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Other Names:
  • Transcutaneous Electrical Stimulation
  • Magnetic Stimulation
Experimental: Stimulation
Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.
 Device: Electromagnetic Neuromodulation
Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
Other Names:
  • Transcutaneous Electrical Stimulation
  • Magnetic Stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Urine flow and volume [ Time Frame: Months 1-48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331979


Contacts
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Contact: Daniel Lu, MD PhD 310-825-4321 dclu@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Daniel C Lu, MD PhD    310-267-2975    dclu@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
More Information
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Responsible Party: Daniel Lu, MD, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02331979    
Other Study ID Numbers: 14-000932
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries