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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.

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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

Phase 1

Primary location

University of Michigan

Ann Arbor, Michigan, 48912, United States

Location status: Recruiting

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. Tolerability of the TENS device

    Time frame: 14 months

    • Proportion of subjects who are able to complete the trial
    • Proportion of 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: 14 months

    To assess the mean change in the GCSI Total score (0-4 where higher score reflects greater severity) after the TENS intervention.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dinesh Khanna, MD, MSc

CONTACT

[email protected]

734-936-5615

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
2026
Study completion
2026
First posted
Oct 17, 2024
Registry last updated
Jul 3, 2025

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.

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