RECRUITING

Thoracic Neuromodulation for Diabetic Gastroparesis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Thoracic Neuromodulation for Diabetic Gastroparesis

Quick Facts

Study Start:2022-06-27

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05273788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Locations (Sites)

Augusta University

Augusta, Georgia, 30912

United States

Collaborators and Investigators

Sponsor: Augusta University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-27

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2022-06-27

Study Completion Date2025-03-30

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Gastroparesis