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Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis (TEA in SSc)

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ClinicalTrials.gov Identifier: NCT05989763
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : December 4, 2023
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Zsuzsanna Hortobagyi Mcmahan, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Constipation Gastrointestinal Motility Disorder Autonomic Dysfunction Device: Transcutaneous Electrical Acustimulation (TEA) Device: Sham-TEA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Estimated Study Start Date : January 5, 2024
Estimated Primary Completion Date : August 14, 2028
Estimated Study Completion Date : September 1, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcutaneous Electrical Acustimulation (TEA) Device: Transcutaneous Electrical Acustimulation (TEA)
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham Comparator: Sham-TEA Device: Sham-TEA
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in slow colonic transit (SCT) [ Time Frame: baseline, week 4 (visit 2) ]
    slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion


Secondary Outcome Measures :
  1. Change in rectal hyposensitivity as assessed by the anorectal manometry [ Time Frame: baseline, week 4 (visit 2) ]
  2. Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures [ Time Frame: baseline, week 4 (visit 2) ]
  3. Change in autonomic dysfunction as assessed by the COMPASS-31 measures [ Time Frame: baseline, week 4 (visit 2) ]
    This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction

  4. Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ), [ Time Frame: baseline, week 4 (visit 2) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients with SSc-constipation from Aim 1 of the study
  • Patients with SCT (>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)
  • Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.

Exclusion Criteria

-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989763


Contacts
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Contact: Zsuzsanna H McMahan, MD, MHS (M-PI) 7135007531 Zsuzsanna.H.McMahan@uth.tmc.edu
Contact: Sharvari R Kamat 713-500-6898 Sharvari.R.Kamat@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Zsuzsanna H McMahan, MD, MHS (M-PI)    713-500-6883    Zsuzsanna.H.McMahan@uth.tmc.edu   
Contact: Sharvari R Kamat    713-500-6898    Sharvari.R.Kamat@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Zsuzsanna H McMahan, MD, MHS (M-PI) The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Zsuzsanna Hortobagyi Mcmahan, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT05989763    
Other Study ID Numbers: HSC-MS-23-0531
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: December 4, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Autonomic Nervous System Diseases
Primary Dysautonomias
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Constipation
 Pathologic Processes
Signs and Symptoms, Digestive
Connective Tissue Diseases
Skin Diseases
Nervous System Diseases