Thoracic Neuromodulation for Diabetic Gastroparesis

Launched by AUGUSTA UNIVERSITY · Mar 2, 2022

Keywords

ClinConnect Summary

This clinical trial, called the TNM-DGp Trial, is studying a new non-invasive treatment for people suffering from diabetic gastroparesis, a condition that can cause severe stomach issues and greatly reduce quality of life for those with diabetes. The treatment being tested is called Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT), which aims to improve symptoms related to nerve function in the stomach. The researchers want to see if this therapy works better than a placebo (a treatment that looks the same but has no active effect) and to find out how often it should be given for the best results.

To participate in this trial, individuals must be adults under 85 years old who have moderate to severe symptoms of diabetic gastroparesis and have not had recent surgeries or certain gastrointestinal conditions. Participants will receive the treatment and be monitored for changes in their symptoms and overall well-being. This research could lead to new, effective ways to manage diabetic gastroparesis, helping many people feel better and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Outpatient DGp patients with refractory symptoms and total ANMS GCSI-DD score ≥ 2.0 (moderate-severe severity) during screening period;
• • 2. Men or women age less than 85;
• • 3. No known mucosal disease;
• • 4. Speak, write, and understand English (by self-report);
• • 5. 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 Criteria:
• • 1. Postsurgical gastroparesis;
• • 2. Gastrointestinal obstruction;
• • 3. Prior gastric surgery (fundoplication, gastric resection or pyloroplasty);
• • 4. Achalasia, Chronic Intestinal Pseudo-obstruction, Colonic Inertia with one complete spontaneous bowel movement (CSBM) less than every 2 weeks;
• • 5. Active inflammatory bowel disease;
• • 6. Use of opioids greater than 3 times a week and marijuana more than 5 times a week;
• • 7. Change in neuromodulator dosage in last 3 months (tricyclic antidepressants, gabapentin, olanzapine, etc.);
• • 8. Use of sympathomimetics;
• • 9. Seizure history or disorder;
• • 10. Active serious psychiatric illness that would warrant independent attention;
• • 11. Severe, unstable cardiac disease and arrhythmias;
• • 12. Metal implants that are not MR safe, gastric electrical stimulators (GES), deep brain stimulators (DBS), sacral nerve stimulators (SNS), or pacemakers;
• • 13. Pregnant women or nursing mothers;
• • 14. Enteral or parenteral feeding