Improving Bladder Function in SCI by Neuromodulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Bladder Function in SCI by Neuromodulation

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Electromagnetic Neuromodulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation of Non-Naive<br>Evaluate neuromodulation in 6 subjects with prior motor training. | Device: Electromagnetic Neuromodulation<br>* Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.<br>* Other names: Magnetic Stimulation;|
| Experimental: Stimulation of Naive<br>Evaluate neuromodulation in 6 naive subjects. | Device: Electromagnetic Neuromodulation<br>* Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.<br>* Other names: Magnetic Stimulation;|
| Experimental: Stimulation<br>Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects. | Device: Electromagnetic Neuromodulation<br>* Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.<br>* Other names: Magnetic Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine flow and volume |  | Months 1-48 |