The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).

Detailed Description
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In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.

Official Title
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The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury

Conditions
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Spinal Cord Injury, Neurogenic Bladder

Intervention / Treatment
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* Device: Transcutaneous Tibial Nerve Stimulation
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment within 6 weeks of injury Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord. Location and transportation available for follow-up appointments Exclusion Criteria: History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.) History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.) Pregnancy History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.) Morbid obesity Ventilator dependent respiration Significant autonomic dysreflexia during baseline urodynamic study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Tibial Nerve Stimulation<br>Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol. | Device: Transcutaneous Tibial Nerve Stimulation<br>* 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.<br>|
| Sham Comparator: Control<br>Sham stimulation. | Device: Control<br>* 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Infection | All infections were urinary tract infections (UTIs). | about 4 weeks | 
| Number of Participants With Skin Irritation | Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury. | about 4 weeks | 
| Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital |  | about 4 weeks | 
| Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS) | Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's mean change in pain score: [Average of the post-stimulation measurements for all 10 time points] minus [Average of baseline measurements for all 10 time points time point] = [mean change in pain score]. The value reported is the mean of all participants' mean change in pain score. The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain. | baseline, about 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Detrusor Pressure as Evaluated by Urodynamic Study |  | baseline | 
| Maximum Detrusor Pressure as Evaluated by Urodynamic Study |  | 2 weeks | 
| Maximum Bladder Capacity as Evaluated by Urodynamic Study |  | baseline | 
| Maximum Bladder Capacity as Evaluated by Urodynamic Study |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electric stimulation, urodynamic study