The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
1 other identifier
interventional
19
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedStudy Start
First participant enrolled
July 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2017
CompletedResults Posted
Study results publicly available
September 10, 2018
CompletedSeptember 10, 2018
August 1, 2018
1.3 years
October 5, 2015
August 9, 2018
August 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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
Study Arms (2)
Transcutaneous Tibial Nerve Stimulation
EXPERIMENTALTranscutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.
Control
SHAM COMPARATORSham stimulation.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Health Science Center, Houstonlead
- The Institute for Rehabilitation and Research (TIRR)collaborator
- Baylor College of Medicinecollaborator
- Case Western Reserve Universitycollaborator
- University of Houstoncollaborator
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Publications (1)
Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019.
PMID: 30837835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Argyrios Stampas, MD
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Argyrios Stampas, MD
University of Texas at Houston Health Science Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 9, 2015
Study Start
July 12, 2016
Primary Completion
October 27, 2017
Study Completion
October 27, 2017
Last Updated
September 10, 2018
Results First Posted
September 10, 2018
Record last verified: 2018-08