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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05989763
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 72.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Aug 15, 2023
• Anticipated Primary Completion Date: Aug 14, 2028
• Anticipated Study Completion Date: Sep 1, 2029

Arms and Interventions

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

Primary Outcome Measures

1. Change in slow colonic transit (SCT) [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 [baseline, week 4 (visit 2)]

2. Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures [baseline, week 4 (visit 2)]

3. Change in autonomic dysfunction as assessed by the COMPASS-31 measures [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) ), [baseline, week 4 (visit 2)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• Principal Investigator: Zsuzsanna H McMahan, MD, MHS (M-PI), The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Constipation

Study Results

No Results Posted as of Aug 14, 2023