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Clinical Trial

Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) for Grade 3 Diabetic Gastroparesis: Pilot Study

We have developed a novel, safe, noninvasive peripheral nerve treatment using repetitive magnetic stimulation, and have demonstrated improvement in fecal incontinence with neuropathy. The goal of this study is to build on our expertise to conduct a pilot, feasibility study by examining the effect of Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) in patients with Grade 3 DG and upper GI symptoms. We believe magnetic stimulation corrects neuropathy of the gut-brain axis and autonomic dysfunction. In a similar fashion, ThorS-MagNT should improve upper GI symptoms (i.e. GERD, nausea, vomiting, dyspepsia) and drug delivery impaired by autonomic dysfunction (i.e. diabetes, Parkinson?s disease). We look to explore the safety and feasibility of ThorS-MagNT in such corresponding conditions, such as gastroparesis, functional dyspepsia, chronic unexplained nausea/vomiting, cyclical vomiting syndrome, drug-refractory Parkinson?s disease, etc. Our central hypothesis is that ThorS-MagNT will improve autonomic dysfunction, gastric motility, and spino-gut interactions, and thereby, improve upper GI symptoms and symptoms of DG. Our aims are, 1). To evaluate the safety and effectiveness of ThorS-MagNT in patients with Grade 3 Diabetic Gastroparesis and in patients with upper GI symptoms. 2). To determine predictive factors for response to ThorS-MagNT for Diabetic Gastroparesis and upper GI symptoms. ThorS-MagNT will be performed in 36 patients with severe DG or with upper GI symptoms by using low-frequency, low-intensity repetitive magnetic stimulation, bilaterally, around T7 intravertebral space, twice a day for 5 days, with a total 1200 magnetic stimulations per treatment session at 1 Hz. The primary outcome is responder rate, defined as ?30% reduction in the Gastroparesis Cardinal Symptom Index-daily diary (ANMS GCSI-DD) score. Secondary outcomes include sub scores of the ANMS GSCI-DD, effects on gastric emptying time, Patient Global Impression of Improvement (PGI-I), safety, and tolerability. The impact of this work is to develop a novel, safe, and non-invasive treatment for severe DG and upper GI problems that could result in a paradigm shift in management of these conditions.

Eligibility Criteria

  • Inclusion criteria: Persistent upper GI symptoms Men or women age less than 85 No known mucosal disease Exclusion Criteria: 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.

Contact Information

    Dhanush Shimoga

    (706) 721-8609