S1440 Novel Neuromodulation Treatment Using Repetitive Magnetic Stimulation for Diabetic Gastroparesis: Preliminary Results From a Proof-of-Concept Study

Abstract

Introduction: Diabetic gastroparesis (DGp) is chartacterized by autonomic neuropathy, for which there are limited effective treatments. Stimulation of thoracic sympathetic and parasympathetic nerves may improve symptoms in patients with diabetic gastroparesis by enhancing gastric contractility. Our aim was to assess safety and feasibility of a novel, non-invasive treatment, Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT,) for refractory DGp in a proof-of-concept study. Methods: DGp patients, who required hospital admission and without known GI mucosal disease, were included. A mapping procedure in the left and right posterior mid-thoracic regions, using a single-pulse circular 90 mm coil (MAGSTIM, Whitland, UK) determined the location and minimum intensity required to achieve a motor evoked response (MEP) of 10 µV with 50% of trials (resting motor threshold) in the upper rectus abdominis and external oblique muscles. ThorS-MagNT was administered at 50% intensity above motor threshold, using a 70 mm double air film self-cooling coil (MAGSTIM Rapid2) positioned over bilateral pre-determined locations to deliver a total of 1200 stimulations at 1 Hz. Treatments were administered twice daily for five consecutive days. Safety and tolerability data were collected. ANMS GCSI-DD was assessed at baseline and throughout the treatment period. Patients who completed all ten treatments were defined as per protocol. Results: Seven DGp patients (6F; 1M) were enrolled . All subjects tolerated administered treatment sessions. One DGp patient experienced medication-related hypotension-a serious adverse event unrelated to study treatment. After resuscitation and missing one treatment, this subject completed 4 subsequent treatments. One patient reported self-limited tingling and numbness, which resolved after treatment. No other adverse events occurred. In four per protocol subjects, an average of 68.25% reduction in ANMS GCSI-DD score from baseline was observed (Table 1). Two other subjects had an average of 13.95% reduction in ANMS GCSI-DD and one study subject dropped out. Conclusion: ThorS-MagNT appears to be feasible, safe and a promising novel treatment for refractory DGp. Further studies are needed in larger samples to assess its effects on symptoms, hospitalization duration, gastric emptying and safety. Acknowledgement: Supported by the NIDDK Diabetic Complications Consortium grants DK076169 & DK115255.Table 1.: ANMS GCSI-DD scores at baseline versus during treatment.