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Behavioural Intervention

TEA for Constipation in Systemic Sclerosis (TEA in SSc Trial)

N/A
Recruiting
Led By Zsuzsanna H McMahan, MD, MHS (M-PI)
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4 (visit 2)

Summary

This trial will examine whether TEA can improve colonic & rectal function in SSc by enhancing ANS and reducing inflammation.

Who is the study for?
This trial is for patients with systemic sclerosis (SSc) who are experiencing constipation. It's open to those not yet treated for constipation or those still having issues despite stable therapy for a month. Participants should have slow colonic transit or rectal hyposensitivity as defined in the study, but can't join if they have both diarrhea and constipation symptoms.
What is being tested?
The study tests whether transcutaneous electrical acustimulation (TEA), which involves using electrical currents on the skin, can improve bowel function and sensitivity by enhancing autonomic nervous system activity in SSc patients. The effects of TEA versus Sham-TEA (a pretend treatment) are compared.
What are the potential side effects?
While specific side effects aren't listed, TEA generally may cause discomfort at the site of application, muscle twitching, or skin irritation due to the electrical current used during treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 (visit 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 (visit 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in slow colonic transit (SCT)
Secondary study objectives
Change in autonomic dysfunction as assessed by the COMPASS-31 measures

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcutaneous Electrical Acustimulation (TEA)Experimental Treatment1 Intervention
Group II: Sham-TEAPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Acustimulation (TEA)
2021
N/A
~30

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,958 Total Patients Enrolled
1 Trials studying Constipation
255 Patients Enrolled for Constipation
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,797 Total Patients Enrolled
Zsuzsanna H McMahan, MD, MHS (M-PI)Principal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Sham-TEA (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05989763 — N/A
Constipation Research Study Groups: Transcutaneous Electrical Acustimulation (TEA), Sham-TEA
Constipation Clinical Trial 2023: Sham-TEA Highlights & Side Effects. Trial Name: NCT05989763 — N/A
Sham-TEA (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05989763 — N/A
~40 spots leftby Aug 2028
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