Neuromodulation treatment for diabetic gastroparesis
Thoracic Neuromodulation for Diabetic Gastroparesis
This study is testing a new noninvasive treatment for diabetic gastroparesis to see if it can help reduce symptoms and improve quality of life for patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT05273788 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the effectiveness of a novel noninvasive treatment called Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT) for patients suffering from diabetic gastroparesis. The study will randomly assign 48 participants to receive either active treatment at different frequencies or a sham treatment over a five-day period. Researchers will assess changes in symptom severity and quality of life, while also exploring the mechanisms behind any observed effects. The trial is designed to provide preliminary efficacy data and insights into potential moderators of treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with refractory diabetic gastroparesis symptoms lasting over six months and a moderate to severe severity score.
Not a fit: Patients with postsurgical gastroparesis, gastrointestinal obstruction, or certain other gastrointestinal conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms of diabetic gastroparesis and improve patients' quality of life.
How similar studies have performed: While this approach is novel, similar neuromodulation techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Augusta, Georgia
- Augusta University — Augusta, Georgia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.