TENS in Scleroderma

NCT06646913 | Recruiting Phase 1 FDA Device

• 1 other identifier: HUM00246152
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.

Conditions

Scleroderma; Gastroparesis; Systemic Sclerosis (SSc)

Keywords

TENS; Scleroderma; Gastroparesis; Pilot Study; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Tolerability of the TENS device

  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 Outcomes (3)

• Efficacy of TENS in treating Scleroderma-related Gastroparesis

  14 months

• Assessment of the Effect of TENS of Gastroparesis Symptoms

  14 months

• Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis

  14 months

Study Arms (1)

Scleroderma Patients with Gastroparesis Symptoms

EXPERIMENTAL

Device: Transcutaneous Electrical Nerve Stimulation

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

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

Also known as: TENS

Scleroderma Patients with Gastroparesis Symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48912, United States

RECRUITING

Related Publications (4)

• Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.

  PMID: 19558608 BACKGROUND

• Khanna D, Hays RD, Maranian P, Seibold JR, Impens A, Mayes MD, Clements PJ, Getzug T, Fathi N, Bechtel A, Furst DE. Reliability and validity of the University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. Arthritis Rheum. 2009 Sep 15;61(9):1257-63. doi: 10.1002/art.24730.

  PMID: 19714600 BACKGROUND

• McMahan ZH, Kulkarni S, Chen J, Chen JZ, Xavier RJ, Pasricha PJ, Khanna D. Systemic sclerosis gastrointestinal dysmotility: risk factors, pathophysiology, diagnosis and management. Nat Rev Rheumatol. 2023 Mar;19(3):166-181. doi: 10.1038/s41584-022-00900-6. Epub 2023 Feb 6.

  PMID: 36747090 BACKGROUND

• Song G, Trujillo S, Fu Y, Shibi F, Chen J, Fass R. Transcutaneous electrical stimulation for gastrointestinal motility disorders. Neurogastroenterol Motil. 2023 Nov;35(11):e14618. doi: 10.1111/nmo.14618. Epub 2023 Jun 8.

  PMID: 37288650 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse; Gastroparesis; Scleroderma, Systemic

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Dinesh Khanna, MD, MSc

CONTACT

734-936-5615; khannad@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology, University of Michigan Scleroderma Program Director

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 17, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)