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NCT06646913 · ClinicalTrials.gov registry record · Phase 1
TENS in Scleroderma
A Phase 1 study of Gastroparesis and Scleroderma, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06646913: Recruiting Phase 1 study of Gastroparesis and Scleroderma, sponsored by University of Michigan.
NCT06646913 is a Phase 1 study of Gastroparesis and Scleroderma that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 16 participants, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06646913, a Phase 1 study of Gastroparesis and Scleroderma, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Acceptability of the TENS device as demonstrated by: 1. Subjects who are able to complete the trial by reaching the end of the testing period with the device 2. Subjects who utilize the device for at least 80% of the proposed applications.
Conditions Studied
Interventions
- DEVICE Transcutaneous Electrical Nerve Stimulation
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What NCT06646913 shows while recruiting
NCT06646913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Gastroparesis appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous Electrical Nerve Stimulation is the first listed.
NCT06646913 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06646913 about?
NCT06646913 is a clinical study titled "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 ...
What is the current status of trial NCT06646913?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-10-01. Estimated completion is 2026-05.
What conditions does trial NCT06646913 study?
This clinical trial studies the following conditions: Gastroparesis, Scleroderma, Systemic Sclerosis (SSc).
What interventions are being tested in trial NCT06646913?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT06646913?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06646913 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06646913's enrollment target sits among peer trials
16 38th of 44 higher than 7 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroparesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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