Status:
COMPLETED
Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) for Grade 3 Diabetic Gastroparesis: Pilot Study
Lead Sponsor:
Augusta University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Gastroparesis
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
Brief 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 patie...
Detailed Description
The global burden of diabetes, both type 1 (TIDM) and type 2 (T2DM), is increasing. Gastroparesis is an under-recognized and significant complication of diabetes, whose lack of effective treatment has...
Eligibility Criteria
Inclusion
- Previously diagnosed diabetic gastroparesis patients admitted with persistent symptoms after correction of metabolic disturbance;
- Men or women age less than 85;
- No known mucosal disease
Exclusion
- Postsurgical gastroparesis;
- Gastrointestinal obstruction or presence of gastric bezoar;
- Prior gastric surgery (fundoplication, gastric resection or pyloroplasty);
- Active inflammatory bowel disease;
- Eosinophilic gastroenteritis;
- Connective tissue disease;
- Chronic liver disease;
- Use of opioids, tricyclic antidepressants;
- Active depression;
- Severe cardiac disease and arrhythmias;
- Metal implants, including gastric electrical stimulators (GES) deep brain stimulators (DBS), sacral nerve stimulators (SNS), or pacemakers;
- Pregnant women or nursing mothers.
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04706832
Start Date
November 5 2020
End Date
December 30 2022
Last Update
January 30 2025
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30912