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

NCT04706832 | Completed Early Phase 1 FDA Device

• 3 other identifiers: ThorS-MagNTU24DK115255-04U24DK076169-13
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic gastroparesis (DG) is an under recognized and significant complication of diabetes with lack of effective treatments. Recently, a 4-fold increase in hospitalizations has been seen in DG patients with refractory symptoms, defined as Grade 3 gastroparesis. A critical barrier to progress has been both a lack of pathophysiological understanding of DG and absence of effective treatments. Diabetic autonomic neuropathy is felt to be a key dysfunction in DG that causes gastric atony and segmental hypomotility of the small intestine. Autonomic testing of DG patients reveals significant sympathetic hypofunction, a feature distinguishing DG from diabetics with normal gastric emptying. Therefore, stimulation of the thoracic dorsal roots of the greater splanchnic nerve (sympathetic stimulation) could enhance gastric motility, as observed in animal models, and improve DG. Investigators 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. The aims are to evaluate the safety, effectiveness and feasibility of ThorS-MagNT in patients with Grade 3 DG and to evaluate predictive factors of treatment. The central hypothesis is that ThorS-MagNT will improve sympathetic hypofunction, gastric motility, and spino-gut interactions, and thereby, improve symptoms of DG. ThorS-MagNT will be performed in 12 patients hospitalized with severe DG 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 ≥20% reduction in the Gastroparesis Cardinal Symptom Index-daily diary (ANMS GCSI-DD) score. Secondary outcomes include subscores 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 that could result in a paradigm shift in management of DG.

Conditions

Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Responder rate

  The responder rate is defined as an improvement in the Gastroparesis Cardinal Symptom Index-daily diary (ANMS GCSI-DD) score (e.g., \>20% decrease in total symptom score from baseline) in at least 50% of the days of treatment.

  1 week

Secondary Outcomes (3)

• Sub-scores of the ANMS GSCI-DD

  1 week

• Gastric emptying time

  3 weeks

• Patient Global Impression of Improvement (PGI-I)

  3 weeks

Study Arms (1)

ThorS-MagNT Treatment

OTHER

Low-frequency, low-intensity repetitive magnetic stimulation bilaterally at T7-8 intravertebral space twice a day for 5 days with a total 1200 magnetic stimulations per treatment session at 1 Hz.

Device: Thoracic Splanchnic Magnetic Neuromodulation Therapy

Interventions

Thoracic Splanchnic Magnetic Neuromodulation Therapy DEVICE

ThorS-MagNT is performed by low-frequency, low-intensity repetitive magnetic stimulation bilaterally around T7-8 intervertebral space twice a day for 5 days with a total 1200 magnetic stimulations per treatment session at 1 Hz.

Also known as: ThorS-MagNT

ThorS-MagNT Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously diagnosed diabetic gastroparesis patients admitted with persistent symptoms after correction of metabolic disturbance;
• Men or women age less than 85;
• No known mucosal disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• Karunaratne T, Yan Y, Eubanks A, Inman B, Rao S, Sharma A. Thoracic Spinal Nerve Neuromodulation Therapy for Diabetic Gastroparesis: A Proof-of-Concept Study. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2958-2959.e3. doi: 10.1016/j.cgh.2022.09.012. Epub 2022 Sep 22. No abstract available.

  PMID: 36152902 DERIVED

Study Officials

• Amol Sharma, MD, MS

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention type: FDA regulated device

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: November 5, 2020
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)