Actively Recruiting
Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator
Led by University of Aarhus · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aalborg University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and above
- Able to read and understand Danish
- Have an implanted gastric electrical stimulator for treating gastroparesis
- Report symptom improvement scores of 0 or 1 (non-responders) or 3 or 4 (responders) on the Likert scale
- Have personally signed and dated informed consent documents
- Willing and able to comply with scheduled visits and trial procedures
You will not qualify if you...
- Previous surgery on the vagus nerve, including cervical vagotomy
- Prior thoracic, abdominal, or brain surgeries that may limit data collection or interpretation
- Previous diagnosis or history of orthostatic intolerance such as POTS, neurocardiogenic syncope, orthostatic hypotension, or autonomic dysfunction
- Having an implanted cardiac device like a pacemaker or vagal nerve stimulator
- History of neurological disease that may limit data collection or interpretation
- Any clinical abnormalities that increase risk or interfere with trial results according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of hepatology and gastroenterology, Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
D
Ditte Kornum, MD
CONTACT
A
Asbjørn Drewes, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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