RECRUITING

Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder

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Conditions

Spinal Cord Injurieselectric stimulationSCIspinal cord injuryneurogenic bladder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.

Official Title

Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder

Quick Facts

Study Start:2020-06-08
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04350359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-75 years old
  2. * Traumatic or non-traumatic SCI
  3. * Admitted to inpatient rehabilitation within 6 weeks
  4. * T9 level of injury and above who are at greatest risk of morbid NGB
  5. * Regionally located to allow follow-up
  6. * English or Spanish speaking
  1. * History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
  2. * History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
  3. * History of peripheral neuropathy
  4. * pre-SCI symptoms of peripheral neuropathy (numbness and/or tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.)
  5. * Pregnancy
  6. * Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy
  7. * concern for tibial nerve pathway injury
  8. * absence of toe flexion or autonomic dysreflexia during electric stimulation test
  9. * Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis

Contacts and Locations

Study Contact

Argyrios Stampas, MD
CONTACT
713-797-5938
argyrios.stampas@uth.tmc.edu

Principal Investigator

Argyrios Stampas, MD
PRINCIPAL_INVESTIGATOR
UTHealth and TIRR Mermorial Hermann
Suzanne Groah, MD
PRINCIPAL_INVESTIGATOR
MedStar National Rehabilitation Hospital

Study Locations (Sites)

MedStar National Rehabilitation Hospital
Washington, District of Columbia, 20010
United States
TIRR Memorial Hermann Research Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Argyrios Stampas, MD, PRINCIPAL_INVESTIGATOR, UTHealth and TIRR Mermorial Hermann
  • Suzanne Groah, MD, PRINCIPAL_INVESTIGATOR, MedStar National Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-08
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2020-06-08
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • electric stimulation
  • SCI
  • spinal cord injury
  • neurogenic bladder

Additional Relevant MeSH Terms

  • Spinal Cord Injuries