Skip to main content
OpenTrials
Completed

NCT Number: NCT06646913

TENS 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Scleroderma Connective Tissue Diseases Digestive System Diseases Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Scleroderma, Diffuse Scleroderma, Systemic Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Systemic Sclerosis (SSc)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Transcutaneous electrical nerve stimulation

Device

Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.

Other names: TENS

Primary outcomes

  1. Acceptability of the TENS Device

    Time frame: 4 weeks

    Acceptability of the TENS device as demonstrated by:

    • Subjects who are able to complete the trial by reaching the end of the testing period with the device
    • Subjects who utilize the device for at least 80% of the proposed applications.

Secondary outcomes

  1. Efficacy of TENS in Treating Scleroderma-related Gastroparesis

    Time frame: 4 weeks

    Mean change in the GCSI Total score (0-4 where higher score reflects greater severity)from baseline to after the TENS intervention.

  2. Assessment of the Effect of TENS of Gastroparesis Symptoms

    Time frame: 4 weeks

    Mean change in the ULCA-GIT 2.0 Distention/Bloating scale (0-3.0 where 0 is lowest severity and 3.0 is greatest severity) from baseline to after the TENS intervention.

  3. Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis

    Time frame: 8 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. The CTCAE v5.0 is a standardize tool to grade adverse events on a scale of 1 to 5, where 1 is "mild" grade 2 is "moderate", 3 is "severe", 4 is "life threatening", and 5 is "death".

    Outcome is shown as number of participants who experienced an adverse event in each possible grade.

  4. Gastric Motility in Participants

    Time frame: 4 weeks

    Participants were categorized as having "normal" or "abnormal" gastric motility at baseline. Those who were categorized as "abnormal" at baseline repeated the test at 4 weeks, after the intervention. Those who were classified as "normal" did not repeat the test.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation in Scleroderma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.