Recruiting

Observational Study

Sponsor:

University of Louisville

Code:

NCT03949660

Conditions

Neurogenic Bowel

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Neurogenic Bowel

Study ID

NCT03949660

Start date

Sep 15, 2018

Status verified date

Oct, 2023

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Sep 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epidural stimulation for blood pressure without stand

To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI

experimental: Epidural stimulation for blood pressure with stand

To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI

experimental: Epidural stimulation for trunk and core without stand

To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI

experimental: Epidural stimulation for trunk and core with stand

To assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI

Interventions

Stimulation for blood pressure without stand

Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.

Stimulation for blood pressure with stand

Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.

Stimulation for trunk and core without stand

Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.

Stimulation for trunk or core with stand

Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.

Primary outcome measure

  • Wireless Motility Capsule [ Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months. ]
  • Ambulatory blood pressure and heart rate monitoring [ Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months. ]
  • Anorectal Manometry (ARM) [ Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months. ]
  • Bowel Diary [ Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months. ]
  • International spinal cord injury bowel function basic data set (Version 2.0) [ Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months. ]
  • Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management. [ Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months. ]
  • Interviews [ Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months. ]

Central Contacts and Locations

Central contacts

Susan Harkema, PhD

502-581-8747susan.harkema@louisville.edu

Lee Ann Zeller-Noe

502-581-8747lee.zellernoe@louisville.edu

Locations

Frazier Rehab Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Susan Harkema, PhD

502-581-8747

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

More Information

Sponsor

University of Louisville

Last update posted

Oct 27, 2023

Last verified

Oct, 2023

Keywords

  • bowel
  • spinal cord injury
  • epidural stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2023-10-27.