Actively Recruiting
Investigation of the Putative Mechanisms Underlying the Symptom-lowering Effect of the Enterra Medical Gastric Electrical Stimulator for Gastroparesis Treatment
Led by University of Aarhus · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the effects of gastric electrical stimulation in people with gastroparesis who have an implanted gastric electrical stimulator but continue to experience symptoms despite medication. The study aims to understand why some patients respond well to the stimulation with symptom relief while others do not. Specifically, it investigates two possible ways the stimulation might work: by affecting brain and brainstem activity through parasympathetic vagal nerve activity, and by improving stomach function such as gastric accommodation. Participants include up to thirty adults with drug-resistant gastroparesis who have a gastric electrical stimulator implanted. They are divided into two groups: responders who had substantial symptom improvement and non-responders with little improvement. The study uses tests like electroencephalography (EEG) to monitor brain activity, electrocardiography (ECG) to assess heart autonomic regulation, and gastric ultrasound to evaluate stomach responses. These measurements are taken during different stimulation intensities, before and after activating the stimulator, and after eating. During a single study day, participants undergo these tests to observe changes caused by the stimulation. Researchers compare brain signals, heart regulation, and stomach activity between responders and non-responders. The main outcome measure is brain evoked potentials during maximum stimulation, with additional secondary measures including EEG and ECG changes, gastric accommodation, tension, contraction frequency, and symptom assessments. The findings may help improve stimulation settings and patient selection for this therapy. The study concludes by October 2025.
CONDITIONS
Brief 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 as 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 the scheduled visit and trial procedures
You will not qualify if you...
- Previous surgery on the vagus nerve, including cervical vagotomy
- Prior thoracic, abdominal, or brain surgeries limiting data collection or interpretation
- Previous diagnosis or history of orthostatic intolerance, such as POTS, neurocardiogenic syncope, or autonomic dysfunction
- Having an implanted cardiac device or vagal nerve stimulator
- History of neurological disease limiting data collection or interpretation
- Any clinical abnormalities increasing risk or interfering with trial results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session lasting approximately 5 minutes per measurement
Participants undergo measurements of brain, heart, and stomach activity using EEG, ECG, and ultrasound during different stimulation intensities of their implanted gastric electrical stimulator.
1 visit (in-person)
Duration - Up to study completion
Participants are observed to assess symptom changes and physiological responses related to their implanted gastric electrical stimulator over time.
Additional assessments may occur depending on cohort assignment
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
A
Asbjørn Drewes, MD
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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