Project Details
Description
Project Summary/Abstract
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. Our lab has developed and refined a novel, non-
invasive, neuromodulation treatment, Thoracic Spinal Nerve Magnetic Neuromodulation Therapy
(ThorS-MagNT). In our uncontrolled trial of adults with diabetic gastroparesis, ThorS-MagNT has
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. We 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). We will test the hypothesis that ThorS-MagNT will improve
visceral afferent neuropathy, autonomic and gastric dysfunction, compared to sham. We 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. Our 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.
Status | Active |
---|---|
Effective start/end date | 7/15/22 → 5/31/24 |
Funding
- National Institute of Diabetes and Digestive and Kidney Diseases: $283,113.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $270,693.00
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