Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
16 participants
INTERVENTIONAL
2024-10-01
2026-05-31
Brief Summary
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To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma.
Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Scleroderma Patients with Gastroparesis Symptoms
Transcutaneous Electrical Nerve Stimulation
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
Interventions
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Transcutaneous Electrical Nerve Stimulation
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>= 18 years
3. English speaking.
4. Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
5. Stable GI specific therapy including prokinetics over the last 4 weeks.
Exclusion Criteria
2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
3. Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
4. Known allergy to adhesive ECG electrodes.
5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Dinesh Khanna, MD, MS
Professor of Rheumatology, University of Michigan Scleroderma Program Director
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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References
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Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.
Khanna D, Hays RD, Maranian P, Seibold JR, Impens A, Mayes MD, Clements PJ, Getzug T, Fathi N, Bechtel A, Furst DE. Reliability and validity of the University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. Arthritis Rheum. 2009 Sep 15;61(9):1257-63. doi: 10.1002/art.24730.
McMahan ZH, Kulkarni S, Chen J, Chen JZ, Xavier RJ, Pasricha PJ, Khanna D. Systemic sclerosis gastrointestinal dysmotility: risk factors, pathophysiology, diagnosis and management. Nat Rev Rheumatol. 2023 Mar;19(3):166-181. doi: 10.1038/s41584-022-00900-6. Epub 2023 Feb 6.
Song G, Trujillo S, Fu Y, Shibi F, Chen J, Fass R. Transcutaneous electrical stimulation for gastrointestinal motility disorders. Neurogastroenterol Motil. 2023 Nov;35(11):e14618. doi: 10.1111/nmo.14618. Epub 2023 Jun 8.
Other Identifiers
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HUM00246152
Identifier Type: -
Identifier Source: org_study_id
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