TENS in Scleroderma

June 30, 2025 updated by: Dinesh Khanna, MD, MS, University of Michigan

Transcutaneous Electrical Nerve Stimulation in Scleroderma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48912
        • Recruiting
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scleroderma Patients with Gastroparesis Symptoms
Device: Transcutaneous Electrical Nerve Stimulation
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
Other Names:
  • TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of the TENS device
Time Frame: 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.
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of TENS in treating Scleroderma-related Gastroparesis
Time Frame: 14 months
To assess the mean change in the GCSI Total score (0-4 where higher score reflects greater severity) after the TENS intervention.
14 months
Assessment of the Effect of TENS of Gastroparesis Symptoms
Time Frame: 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.
14 months
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Time Frame: 14 months
To evaluate the number of participants with treatment-related adverse events as assessed by CTCAE v5.0
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00246152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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