TENS in Scleroderma

University of Michigan

Status and phase: Enrolling; Phase 1

Conditions: Gastroparesis; Scleroderma; Systemic Sclerosis (SSc)

Treatments: Device: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06646913

HUM00246152

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Scleroderma Patients with Gastroparesis Symptoms

Experimental group

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation