Systemic SclerosisTEA in SScNCT05989763
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
A study testing Transcutaneous Electrical Acustimulation (TEA) in people with Systemic Sclerosis and Constipation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Constipation, Gastrointestinal Motility Disorder
- What is being tested?
- Transcutaneous Electrical Acustimulation (TEA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2024to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Zsuzsanna H McMahan, MD, MHS (M-PI), 713-500-6883, Zsuzsanna.H.McMahan@uth.tmc.edu
Sharvari R Kamat, 713-500-6898, Sharvari.R.Kamat@uth.tmc.edu
About this study
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.
- Conditions
- Systemic Sclerosis, Constipation, Gastrointestinal Motility Disorder, Autonomic Dysfunction
- Being tested
- Transcutaneous Electrical Acustimulation (TEA), Sham-TEA
- Medical subject headings
- Scleroderma, Systemic, Constipation, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Acustimulation (TEA)Device
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham-TEADevice
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental | Not described Receives: Device: Transcutaneous Electrical Acustimulation (TEA) |
| Sham-TEA | Sham comparator | Not described Receives: Device: Sham-TEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in slow colonic transit (SCT)
slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion
Measured: baseline, week 4 (visit 2)
Secondary outcomes (4)
Change in rectal hyposensitivity as assessed by the anorectal manometry
Measured: baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Measured: baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the COMPASS-31 measures
This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction
Measured: baseline, week 4 (visit 2)
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
Measured: baseline, week 4 (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start17 Feb 2024
- Primary completion14 Aug 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Zsuzsanna Hortobagyi Mcmahan, The University of Texas Health Science Center, Houston
- Investigators
- Zsuzsanna H McMahan, MD, MHS (M-PI), Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989763
- Sponsor's protocol ID
- HSC-MS-23-0531
- Other IDs
- 1R01AR081382-01A1
- Acronym
- TEA in SSc
- Status last verified
- Jun 2025
- First submitted
- 4 Aug 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05989763
- Acronym / sponsor ID
- TEA in SSc / HSC-MS-23-0531
- Conditions
- Systemic Sclerosis, Constipation, Gastrointestinal Motility Disorder, Autonomic Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 14 Aug 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental | Device: Transcutaneous Electrical Acustimulation (TEA) |
| Sham-TEA | Sham comparator | Device: Sham-TEA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA)TEA will then be administrated for 1 hour twice daily for a period of 4 weeks | Device | Transcutaneous Electrical Acustimulation (TEA) |
| Sham-TEASham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks | Device | Sham-TEA |
Primary outcome
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
4 secondary outcomes
Change in rectal hyposensitivity as assessed by the anorectal manometry
Time frame: baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Time frame: baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the COMPASS-31 measures
Time frame: baseline, week 4 (visit 2)
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
Time frame: baseline, week 4 (visit 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zsuzsanna H McMahan, MD, MHS (M-PI) principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Acustimulation (TEA) in people with Systemic Sclerosis and Constipation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zsuzsanna H McMahan, MD, MHS (M-PI) (7135007531, Zsuzsanna.H.McMahan@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in slow colonic transit (SCT) (time frame: baseline, week 4 (visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.