Transcutaneous Electrical Nerve Stimulation in Scleroderma

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Dinesh Khanna, MD, MSc
khannad@med.umich.edu
734-936-5615
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 16
Treatments
Experimental: Scleroderma Patients with Gastroparesis Symptoms
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov