NCT06582576 Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator
| NCT ID | NCT06582576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Gastroparesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-09-02 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06582576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06582576 currently recruiting?
Yes, NCT06582576 is actively recruiting participants. Contact the research team at Dittiver@rm.dk for enrollment information.
Where is the NCT06582576 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT06582576 clinical trial?
NCT06582576 is sponsored by University of Aarhus. The trial plans to enroll 30 participants.