Status:
RECRUITING
Thoracic Neuromodulation for Diabetic Gastroparesis
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Conditions:
Diabetic Gastroparesis
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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 dia...
Detailed Description
The proposed TNM-DGp trial is a pilot sham-controlled RCT to test the preliminary efficacy of ThorS-MagNT to improve DGp symptom severity and related quality of life. The investigators will also explo...
Eligibility Criteria
Inclusion
- Outpatient DGp patients with refractory symptoms and total ANMS GCSI-DD score ≥ 2.0 (moderate-severe severity) during screening period;
- Men or women age less than 85;
- No known mucosal disease;
- Speak, write, and understand English (by self-report);
- On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.
Exclusion
- Postsurgical gastroparesis;
- Gastrointestinal obstruction;
- Prior gastric surgery (fundoplication, gastric resection or pyloroplasty);
- Achalasia, Chronic Intestinal Pseudo-obstruction, Colonic Inertia with one complete spontaneous bowel movement (CSBM) less than every 2 weeks;
- Active inflammatory bowel disease;
- Use of opioids greater than 3 times a week and marijuana more than 5 times a week;
- Change in neuromodulator dosage in last 3 months (tricyclic antidepressants, gabapentin, olanzapine, etc.);
- Use of sympathomimetics;
- Seizure history or disorder;
- Active serious psychiatric illness that would warrant independent attention;
- Severe, unstable cardiac disease and arrhythmias;
- Metal implants that are not MR safe, gastric electrical stimulators (GES), deep brain stimulators (DBS), sacral nerve stimulators (SNS), or pacemakers;
- Pregnant women or nursing mothers;
- Enteral or parenteral feeding
Key Trial Info
Start Date :
July 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05273788
Start Date
July 27 2022
End Date
May 31 2026
Last Update
September 3 2025
Active Locations (1)
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1
Augusta University
Augusta, Georgia, United States, 30912