Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach..
- Who it may be relevant to
- Registry conditions: Gastroparesis, Vomiting, Nausea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of the Putative Mechanisms Underlying the Symptom-lowering Effect of the Enterra Medical Gastric Electrical Stimulator for Gastroparesis Treatment
Overview
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.
Interventions
- Diagnostic test Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach.
Measuring EEG, ECG, and ultrasound in both groups during different stimulation intensities provided by the previously implanted gastric electrical stimulator.
Primary outcome measures
- Evoked brain potentials [Time frame: 5min during maximum stimulation intensity]
Secondary outcome measures (9)
- EEG measures between ON/OFF stimulation [Time frame: 5min]
- Meal-related EEG measures [Time frame: 5min]
- ECG measures between ON/OFF stimulation [Time frame: 5min]
- ECG measures between stimulation intensities [Time frame: 5min]
- Meal-related ECG measures [Time frame: 5min]
- Meal-related gastric accomodation [Time frame: 5min]
- Meal-related gastric tension [Time frame: 5min]
- Meal-related gastric contraction frequency [Time frame: 5min]
- Symptoms and gastric measures [Time frame: 5min]
Eligibility criteria
Inclusion criteria
- Age 18 and above
- Able to read and understand Danish
- Have an implanted gastric electrical stimulator for treating gastroparesis
- Answering 0 or 1 (non-responders) or 3 or 4 (responders) on the Likert scale describing the symptom improvement gained by gastric electrical stimulation.
- Personally signed and dated the informed consent documents ("Informeret samtykke") indicating that the patient has been informed of all pertinent aspects of the trial
- Are willing and able to comply with the scheduled visit and trial procedures
Exclusion criteria
- Previous surgery on the vagus nerve, including cervical vagotomy
- Prior thoracic, abdominal or brain surgeries that, in the opinion of the investigator, could limit data collection or interpretation.
- Previous diagnosis or history of orthostatic intolerance, e.g. POTS, neurocardiogenic syncope, orthostatic hypotension or autonomic dysfunction.
- Patients with an implanted cardiac device (e.g. pacemaker, CRT, etc.) or vagal nerve stimulator (VNS).
- History of neurological disease that, in the opinion of the investigator, could limit data collection or interpretation.
- Participants with any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Department of hepatology and gastroenterology, Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT06582576 · GES - mechanisms of action