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NCT05273788 · ClinicalTrials.gov registry record · Phase 1
Thoracic Neuromodulation for Diabetic Gastroparesis
A Phase 1 study of Diabetic Gastroparesis, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT05273788: Recruiting Phase 1 study of Diabetic Gastroparesis, sponsored by Medical University of South Carolina.
NCT05273788 is a Phase 1 study of Diabetic Gastroparesis that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 48 participants, below the 155-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05273788, a Phase 1 study of Diabetic Gastroparesis, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The global incidence of diabetes is rising. Gastroparesis is a significant complication of diabetes that results in debilitating symptoms and affects quality of life. Current treatment options for diabetic gastroparesis are limited. Significant visceral afferent neuropathy is associated with diabetic gastroparesis and sympathetic overactivity is seen in nausea, both type 1 and 2 diabetes, and diabetic complications. These dysfunctions can result from neuropathy affecting the thoracic spinal nerves that carry both general visceral afferents and preganglionic sympathetic efferents in the greater splanchnic nerve, innervating the foregut. Neuromodulation of the thoracic spinal nerves should improve diabetic gastroparesis symptoms and restore quality of life by improving neuropathy and gastric sensori-motor function. The investigators has developed and refined a novel, noninvasive, neuromodulation treatment, Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT). In an uncontrolled trial of adults with diabetic gastroparesis, ThorS-MagNT the investigators demonstrated feasibility, acceptability, and improvement of DGp symptoms. Whether active neuromodulation is better than sham therapy and the optimal frequency of treatment are not known. The investigators propose to conduct a dose-ranging, sham-controlled trial (pilot NIH Stage 1b) to assess the effect of ThorS-MagNT on symptom severity and quality of life in diabetic gastroparesis (TNM-DGp Trial). The investigators will test the hypothesis that ThorS-MagNT will improve visceral afferent neuropathy, autonomic and gastric dysfunction, compared to sham. The investigators will also test whether any improvements are due to neuromodulation of (a) peripheral spino-gut axis or (b) central structures of the limbic system and autonomic network, or both. Successful completion of this pilot study will provide insights into gastroparesis disease processes and inform mechanisms of action of neuromodulation therapy in
Primary Outcome
Responder is defined as ≥30% reduction n gastroparesis symptom severity score by the Week 4 total ANMS GCSI-DD score compared to baseline.
Conditions Studied
Interventions
- DEVICE 2400 ThorS-MagNT Stimulations at 1Hz
- DEVICE 2400 ThorS-MagNT Stimulations at 10Hz
- DEVICE Sham Stimulations
Study Locations (1)
Georgia
- Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-07-27 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What NCT05273788 shows while recruiting
NCT05273788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 155-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Diabetic Gastroparesis appearing as the primary indexed condition, and to 3 interventions - of which 2400 ThorS-MagNT Stimulations at 1Hz is the first listed.
NCT05273788 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05273788 about?
NCT05273788 is a clinical study titled "Thoracic Neuromodulation for Diabetic Gastroparesis". The global incidence of diabetes is rising. Gastroparesis is a significant complication of diabetes that results in debilitating symptoms and affects quality of life. Current treatment options for diabetic gastroparesis are limited. Significant visceral afferent neuropathy is associated with diabeti...
What is the current status of trial NCT05273788?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-07-27. Estimated completion is 2026-05-31.
What conditions does trial NCT05273788 study?
This clinical trial studies the following conditions: Diabetic Gastroparesis.
What interventions are being tested in trial NCT05273788?
The interventions under investigation include: 2400 ThorS-MagNT Stimulations at 1Hz (DEVICE), 2400 ThorS-MagNT Stimulations at 10Hz (DEVICE), Sham Stimulations (DEVICE).
Who is sponsoring clinical trial NCT05273788?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05273788 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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