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Behavioural Intervention
TEA for Constipation in Systemic Sclerosis (TEA in SSc Trial)
N/A
Waitlist Available
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)
Awards & highlights
TEA in SSc Trial 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.Check my eligibility
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.See study design
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.
TEA in SSc Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4 (visit 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 (visit 2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in slow colonic transit (SCT)
Secondary outcome measures
Change in autonomic dysfunction as assessed by the COMPASS-31 measures
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) )
+1 moreTEA in SSc 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
483 Previous Clinical Trials
1,086,880 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,917 Total Patients Enrolled
Zsuzsanna H McMahan, MD, MHS (M-PI)Principal InvestigatorThe University of Texas Health Science Center, Houston
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience both diarrhea and constipation, but mainly have diarrhea.I have constipation and haven't started treatment or it hasn't improved with current treatment.Patients with constipation related to systemic sclerosis from the first part of the study.You still have a lot of the markers left in your colon 5 days after swallowing the capsule, or you have a condition called RH.
Research Study Groups:
This trial has the following groups:- Group 1: Transcutaneous Electrical Acustimulation (TEA)
- Group 2: Sham-TEA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to join this clinical experiment?
"The information presented on clinicaltrials.gov shows that this trial, which first appeared August 15th 2023, is not actively enrolling patients at the moment. However, 633 other trials are currently recruiting participants across various medical centres."
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