Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Not Applicable

Completed

• Conditions: Scleroderma; Gastroparesis

• Registration Number: NCT03294616
• Lead Sponsor: Johns Hopkins University

Brief Summary

An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-06
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-27
• Primary Completion: 2019-06-30
• Status Verified: 2019-11
• Study Completion: 2019-11-20
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• No any systemic diseases;
• no scleroderma; no history of gastrointestinal surgery;
• no dyspeptic symptoms during the past 2 weeks;
• not taking any medications except contraceptives during the past 2 weeks;
• age 18 and older.

Exclusion Criteria

• History of any systemic diseases or surgeries;
• allergic to adhesives; pregnancy;
• unable to sign the consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	70 days	a validated method including 9 symptoms will be used to assess GI symptoms

Secondary Outcome Measures

Name	Time	Method
effects of TEA on autonomic function	70 days	60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
effects of TEA on GI hormones and inflammatory cytokine	70 days	60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
effects of TEA on gastric motility	70 days	visit 4 in chronic phase; breath test will be used to assess gastric emptying

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States