Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582576
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Putative Mechanisms Underlying the Symptom-lowering Effect of the Enterra Medical Gastric Electrical Stimulator for Gastroparesis Treatment
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Gastric electrical stimulation applied by a surgically implanted device effectively alleviates upper gastrointestinal symptoms in the majority of individuals with medically refractory gastroparesis Despite its efficacy the mechanisms of action have been minimally explored in previous studies and it is unknown why some individuals experience limited symptom-lowering effects
Aim The investigators aim to investigate two of the potential mechanisms of action leading to symptom-reducing effects of gastric electrical stimulation 1 possible central effects in the brainstem and brain by enhanced parasympathetic vagal activity and 2 peripheral effects in the stomach by improved gastric accommodation
Methods Up to thirty individuals with drug-refractory gastroparesis having an implanted gastric electrical stimulator will be enrolled in this cross-sectional and observational study Of these 15 will be responders substantial symptomatic improvement and 15 non-responders minor symptomatic improvement Electroencephalography EEG will evaluate the stimulation-induced activity in the brain and brainstem to assess whether the gastric stimulation generates evoked potentials Electrocardiography ECG will investigate stimulation-induced changes in the autonomic regulation of the heart Gastric ultrasound will investigate the effect of stimulation on stomach accommodation contractions and wall tension These central and peripheral measures will be assessed during one study day before and after activating the gastric electrical stimulator following an increase in stimulation intensity and post-meal consumption Furthermore results will be compared between responders and non-responders
Perspectives Adjusting the parameters of gastric electrical stimulation based on objective markers in the brain heart or stomach rather than relying on symptom fluctuations may enhance the effectiveness of symptom improvement In the future these objective markers may aid in differentiating between responders and non-responders which may lead to optimised selection criteria for surgery
Aim The investigators aim to investigate two of the potential mechanisms of action leading to symptom-reducing effects of gastric electrical stimulation 1 possible central effects in the brainstem and brain by enhanced parasympathetic vagal activity and 2 peripheral effects in the stomach by improved gastric accommodation
Methods Up to thirty individuals with drug-refractory gastroparesis having an implanted gastric electrical stimulator will be enrolled in this cross-sectional and observational study Of these 15 will be responders substantial symptomatic improvement and 15 non-responders minor symptomatic improvement Electroencephalography EEG will evaluate the stimulation-induced activity in the brain and brainstem to assess whether the gastric stimulation generates evoked potentials Electrocardiography ECG will investigate stimulation-induced changes in the autonomic regulation of the heart Gastric ultrasound will investigate the effect of stimulation on stomach accommodation contractions and wall tension These central and peripheral measures will be assessed during one study day before and after activating the gastric electrical stimulator following an increase in stimulation intensity and post-meal consumption Furthermore results will be compared between responders and non-responders
Perspectives Adjusting the parameters of gastric electrical stimulation based on objective markers in the brain heart or stomach rather than relying on symptom fluctuations may enhance the effectiveness of symptom improvement In the future these objective markers may aid in differentiating between responders and non-responders which may lead to optimised selection criteria for surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None