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NCT04706832 · ClinicalTrials.gov registry record · Early Phase 1
Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) for Grade 3 Diabetic Gastroparesis: Pilot Study
A Early Phase 1 study, sponsored by Augusta University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT04706832: Completed Early Phase 1 study, sponsored by Augusta University.
NCT04706832 is a Early Phase 1 study that has completed, run by Augusta University. The registered enrollment target is 7 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04706832, a Early Phase 1 study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Diabetic gastroparesis (DG) is an under recognized and significant complication of diabetes with lack of effective treatments. Recently, a 4-fold increase in hospitalizations has been seen in DG patients with refractory symptoms, defined as Grade 3 gastroparesis. A critical barrier to progress has been both a lack of pathophysiological understanding of DG and absence of effective treatments. Diabetic autonomic neuropathy is felt to be a key dysfunction in DG that causes gastric atony and segmental hypomotility of the small intestine. Autonomic testing of DG patients reveals significant sympathetic hypofunction, a feature distinguishing DG from diabetics with normal gastric emptying. Therefore, stimulation of the thoracic dorsal roots of the greater splanchnic nerve (sympathetic stimulation) could enhance gastric motility, as observed in animal models, and improve DG. Investigators have developed a novel, safe, noninvasive peripheral nerve treatment using repetitive magnetic stimulation, and have demonstrated improvement in fecal incontinence with neuropathy. The goal of this study is to build on our expertise to conduct a pilot, feasibility study by examining the effect of Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) in patients with Grade 3 DG. The aims are to evaluate the safety, effectiveness and feasibility of ThorS-MagNT in patients with Grade 3 DG and to evaluate predictive factors of treatment. The central hypothesis is that ThorS-MagNT will improve sympathetic hypofunction, gastric motility, and spino-gut interactions, and thereby, improve symptoms of DG. ThorS-MagNT will be performed in 12 patients hospitalized with severe DG by using low-frequency, low-intensity repetitive magnetic stimulation, bilaterally, around T7 intravertebral space, twice a day for 5 days, with a total 1200 magnetic stimulations per treatment session at 1 Hz. The primary outcome is responder rate, defined as ≥20% reduction in the Gastroparesis Cardinal Symptom
Primary Outcome
The responder rate is defined as an improvement in the Gastroparesis Cardinal Symptom Index-daily diary (ANMS GCSI-DD) score (e.g., \>20% decrease in total symptom score from baseline) in at least 50% of the days of treatment.
Interventions
- DEVICE Thoracic Splanchnic Magnetic Neuromodulation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-11-05 |
| Est. Completion | 2022-12-30 |
| Phase | Early Phase 1 |
What the finished NCT04706832 record still lists
NCT04706832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Thoracic Splanchnic Magnetic Neuromodulation Therapy is the first listed.
NCT04706832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04706832 about?
NCT04706832 is a clinical study titled "Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) for Grade 3 Diabetic Gastroparesis: Pilot Study". Diabetic gastroparesis (DG) is an under recognized and significant complication of diabetes with lack of effective treatments. Recently, a 4-fold increase in hospitalizations has been seen in DG patients with refractory symptoms, defined as Grade 3 gastroparesis. A critical barrier to progress has b...
What is the current status of trial NCT04706832?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2020-11-05. Estimated completion is 2022-12-30.
What interventions are being tested in trial NCT04706832?
The interventions under investigation include: Thoracic Splanchnic Magnetic Neuromodulation Therapy (DEVICE).
Who is sponsoring clinical trial NCT04706832?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04706832's enrollment target sits among peer trials
7 1826th of 2000 higher than 156 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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