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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR081382-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental |
| |
| Sham-TEA | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Device | TEA will then be administrated for 1 hour twice daily for a period of 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, week 4 (visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rectal hyposensitivity as assessed by the anorectal manometry | baseline, week 4 (visit 2) | |
| Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures | baseline, week 4 (visit 2) |
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Inclusion Criteria
Exclusion Criteria
-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zsuzsanna H McMahan, MD, MHS (M-PI) | Contact | 7135007531 | Zsuzsanna.H.McMahan@uth.tmc.edu | |
| Sharvari R Kamat | Contact | 713-500-6898 | Sharvari.R.Kamat@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zsuzsanna H McMahan, MD, MHS (M-PI) | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Sham-TEA | Device | Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks |
|
| 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 | baseline, week 4 (visit 2) |
| Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ), | baseline, week 4 (visit 2) |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003248 | Constipation |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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