Improving Bowel Function and Quality of Life After Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    36
  • sponsor
    University of Louisville
Updated on 18 November 2021

Summary

Bowel dysfunction is consistently rated as one of the most common complications affecting daily life for individuals with spinal cord injury. The overall objective of this study is to investigate whether the use of specific spinal cord epidural stimulation will affect bowel function. This study will also examine how alterations in bowel function influence quality of life outcomes. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired bowel function.

Description

Participants in this study must be enrolled in the TS - EPI study (IRB# 16.0179) which provides the spinal cord epidural implant and training interventions. You will receive two sets of interventions, each one lasting 80 sessions for a total of 160 sessions. Assessments for bowel function and quality of life will be performed as part of this study and are conducted at baseline/pre-training, post-Intervention 1, post-Intervention 2, and at the 6-month and 12-month follow-ups. Your participation in this study will last up to 24 months.

Details
Condition Neurogenic Bowel
Treatment Stimulation for blood pressure without stand, Stimulation for blood pressure with stand, Stimulation for trunk and core without stand, Stimulation for trunk or core with stand
Clinical Study IdentifierNCT03949660
SponsorUniversity of Louisville
Last Modified on18 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years of age at the time of enrollment
At least 2 years post injury
Non-progressive spinal cord injury
Stable medical condition
Unable to voluntarily move all joints of the legs
Unable to stand independently
Cardiovascular dysfunction including presence of persistent resting low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in 24 hour period
Bowel dysfunction as a result of spinal cord injury

Exclusion Criteria

Ventilator dependent
Untreated painful musculoskeletal dysfunction, unhealed fracture or pressure sore
Untreated psychiatric disorder or ongoing drug abuse
Colostomy bag
Any implanted pump (i.e., baclofen pump, pain pump, etc)
Cardiovascular or bowel dysfunction unrelated to SCI
Ongoing nicotine use
Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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