GastroparesisNCT06582576
Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator
An observational study of Gastroparesis and Vomiting, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Vomiting, Nausea
- What is being tested?
- Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach.
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Sep 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals having an implanted Enterra gastric electrical stimulator for treating gastroparesis. 15 will be included as "responders" and 15 as "non-responders". Using a 5-point Likert scale, each participant will evaluate the experienced symptom-reducing effect of the gastric electrical stimulation. The individuals answering 0 or 1 (minor or no symptom improvement) are defined as responders, while individuals answering 3 or 4 (substantial or full symptom improvement) are defined as responders. Individuals answering 2 will not be included in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of hepatology and gastroenterology, Aarhus University Hospital
Aarhus N, 8200
Ditte Kornum, MD, Dittiver@rm.dk
Klaus Krogh, MD, klaukrog@rm.dk
About this study
Official title: Investigation of the Putative Mechanisms Underlying the Symptom-lowering Effect of the Enterra Medical Gastric Electrical Stimulator for Gastroparesis Treatment
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.
Read more
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
- Gastroparesis, Vomiting, Nausea
- Being tested
- Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach.
- Medical subject headings
- Gastroparesis, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach.Diagnostic test
Measuring EEG, ECG, and ultrasound in both groups during different stimulation intensities provided by the previously implanted gastric electrical stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Responders | Individuals who have a gastric pacemaker for treating gastroparesis and have experienced a "substantial or full" symptomatic improvement after the implantation. Receives: Diagnostic Test: Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach. | |
| Non-responders | Individuals who have a gastric pacemaker for treating gastroparesis and answered have experienced "some or none" symptomatic improvement after the implantation. Receives: Diagnostic Test: Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoked brain potentials
Amplitude of evoked brain potentials induced by gastric electrical stimulation
Measured: 5min during maximum stimulation intensity
Secondary outcomes (9)
EEG measures between ON/OFF stimulation
EEG frequency distribution when comparing the OFF and ON stimulation modes
Measured: 5min
Meal-related EEG measures
EEG frequency distribution in response to an ingested meal when comparing the OFF and ON stimulation modes.
Measured: 5min
ECG measures between ON/OFF stimulation
Heart rate variability, periodic repolarisation dynamic, and the deceleration capacity of the heart rate when comparing the OFF and ON stimulation modes.
Measured: 5min
ECG measures between stimulation intensities
Heart rate variability, periodic repolarisation dynamic, and the deceleration capacity of the heart rate following different stimulation intensities.
Measured: 5min
Meal-related ECG measures
Heart rate variability, periodic repolarisation dynamic, and the deceleration capacity of the heart rate in response to an ingested meal when comparing the OFF and ON stimulation modes.
Measured: 5min
Meal-related gastric accomodation
Gastric accommodation in response to an ingested meal comparing OFF and ON stimulation.
Measured: 5min
Meal-related gastric tension
Gastric tension in response to an ingested meal comparing OFF and ON stimulation.
Measured: 5min
Meal-related gastric contraction frequency
Gastric contraction frequency in response to an ingested meal comparing OFF and ON stimulation.
Measured: 5min
Symptoms and gastric measures
Correlation between gastroparesis symptoms (Gastroparesis Cardinal Symptom Index) and changes in gastric accommodation/tension when turning the stimulation ON after meal ingestion.
Measured: 5min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start2 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582576
- Sponsor's protocol ID
- GES - mechanisms of action
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The final dataset can be provided upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Putative Mechanisms Underlying the Symptom-lowering Effect of the Enterra Medical Gastric Electrical Stimulator for Gastroparesis Treatment
- ClinicalTrials.gov ID
- NCT06582576
- Acronym / sponsor ID
- GES - mechanisms of action
- Conditions
- Gastroparesis, Vomiting, Nausea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | – | Diagnostic Test: Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach.Individuals who have a gastric pacemaker for treating gastroparesis and have experienced a "substantial or full" symptomatic improvement after the implantation. |
| Non-responders | – | Diagnostic Test: Effect of different gastric electrical stimulator stimulation paragdimes on brain, heart, and stomach.Individuals who have a gastric pacemaker for treating gastroparesis and answered have experienced "some or none" symptomatic improvement after the implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals having an implanted Enterra gastric electrical stimulator for treating gastroparesis. 15 will be included as "responders" and 15 as "non-responders". Using a 5-point Likert scale, each participant will evaluate the experienced symptom-reducing effect of the gastric electrical stimulation. The individuals answering 0 or 1 (minor or no symptom improvement) are defined as responders, while individuals answering 3 or 4 (substantial or full symptom improvement) are defined as responders. Individuals answering 2 will not be included in the study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Non-responders, Responders |
Primary outcome
Evoked brain potentials
Time frame: 5min during maximum stimulation intensity
Amplitude of evoked brain potentials induced by gastric electrical stimulation
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. The final dataset can be provided upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Vomiting, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ditte Kornum, MD (40517858, Dittiver@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoked brain potentials (time frame: 5min during maximum stimulation intensity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.