TENS in Scleroderma

Официальное название

Transcutaneous Electrical Nerve Stimulation in Scleroderma

Обзор

The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is: 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.

Вмешательства

• Устройство Transcutaneous Electrical Nerve Stimulation
  Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.

Первичные конечные точки

• Tolerability of the TENS device [Срок оценки: 14 months]

Вторичные конечные точки (3)

• Efficacy of TENS in treating Scleroderma-related Gastroparesis [Срок оценки: 14 months]
• Assessment of the Effect of TENS of Gastroparesis Symptoms [Срок оценки: 14 months]
• Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis [Срок оценки: 14 months]

Критерии участия

Критерии включения

• Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
• Age \>= 18 years
• English speaking.
• Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
• Stable GI specific therapy including prokinetics over the last 4 weeks.

Критерии исключения

• Pregnancy, or currently lactating.
• A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
• Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
• Known allergy to adhesive ECG electrodes.
• Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Публикации

• 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. PMID 19558608
• 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. PMID 19714600
• 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. PMID 36747090
• 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. PMID 37288650

Идентификаторы

NCT: NCT06646913 · HUM00246152

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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