TENS in Scleroderma

Phase 1

Recruiting

• Conditions: Scleroderma; Gastroparesis; Systemic Sclerosis (SSc)

• Registration Number: NCT06646913
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-02
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification 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

1. Pregnancy, or currently lactating.
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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tolerability of the TENS device	14 months	1. Proportion of subjects who are able to complete the trial; 2. Proportion of subjects who utilize the device for at least 80% of the proposed applications.

Secondary Outcome Measures

Name	Time	Method
Efficacy of TENS in treating Scleroderma-related Gastroparesis	14 months	To assess the mean change in the GCSI Total score (0-4 where higher score reflects greater severity) after the TENS intervention.
Assessment of the Effect of TENS of Gastroparesis Symptoms	14 months	To assess the mean change in the GIT 2.0 Distention/Bloating scale (0-3.0 where 0 is lower severity and 3.0 is greater severity) after the TENS intervention.
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis	14 months	To evaluate the number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States