Thoracic Neuromodulation for Diabetic Gastroparesis
Key facts
- Who runs it
- Medical University of South Carolina
- Where
- Augusta, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 36 people enrolled
- Started
- 27 Jul 2022
- Ended
- 30 Jun 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 2400 ThorS-MagNT Stimulations at 1Hz
- 2400 ThorS-MagNT Stimulations at 10Hz
- Sham Stimulations
- Record updated
- 14 September 2026
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior gastric surgery (fundoplication, gastric resection or pyloroplasty)
- Metal implants that are not MR safe, gastric electrical stimulators (GES), deep brain stimulators (DBS), sacral nerve stimulators (SNS), or pacemakers
- Active inflammatory bowel disease
- Seizure history or disorder
- Active serious psychiatric illness that would warrant independent attention
- Severe, unstable cardiac disease and arrhythmias
- Postsurgical gastroparesis
- Gastrointestinal obstruction
- Achalasia, Chronic Intestinal Pseudo-obstruction, Colonic Inertia with one complete spontaneous bowel movement (CSBM) less than every 2 weeks
- 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
- Pregnant women or nursing mothers
- Enteral or parenteral feeding
Where in United States
- Augusta UniversityAugusta, United StatesNo longer taking part
About the trial
What the trial wants to find out
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 addressing disruption of the brain-gut axis. Expected outcomes include development of a novel, non-invasive, safe and efficacious therapy for diabetic gastroparesis. These efforts will inform future true efficacy testing in an NIH Stage 2 trial using multiphase optimization strategy (MOST) design.
The 3 groups in the trial
- 1Hz ArmExisting treatment, for comparison
ThorS-MagNT treatment intervention with 2400 total stimulations at 1Hz with the magnetic coil.
Treatment: 2400 ThorS-MagNT Stimulations at 1Hz
- 10Hz ArmExisting treatment, for comparison
ThorS-MagNT treatment intervention with 2400 total stimulations at 10Hz with the magnetic coil.
Treatment: 2400 ThorS-MagNT Stimulations at 10Hz
- Sham ArmSham treatment, for comparison
Sham intervention with 2400 total sham stimulations with the magnetic coil.
Treatment: Sham Stimulations
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 September 2026