Vagal Nerve Stimulation for Gastric Motor Functions
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a device called a Vagal Nerve Stimulant (VNS) affects stomach functions in people with certain conditions. Researchers are investigating whether this device helps the stomach process and accommodate food better for those already using it for depression or epilepsy that doesn't respond to medication. Suitable candidates for this trial have already had a VNS device implanted for drug-resistant depression or epilepsy and are stable in their condition. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for others.
Will I have to stop taking my current medications?
The trial excludes patients on immunosuppressants, beta blockers, anticholinergics, and clonidine. If you need to change these medications, you must be stable on the new ones for at least one month before starting the trial.
What prior data suggests that this vagal nerve stimulation is safe for gastric motor functions?
Research shows that vagal nerve stimulation (VNS) has been safely used for some time, particularly for treating hard-to-treat depression. Many patients have tolerated it well. Studies also suggest it might help with stomach problems by improving how the stomach empties and adapts to food.
While VNS is usually well-tolerated, some people might experience side effects like voice changes, coughing, or throat discomfort. Serious issues are rare. Since VNS is already approved for certain conditions, it has passed safety checks for those uses. However, treatments can affect everyone differently.
Prospective trial participants should discuss any concerns with their doctor, who can provide advice based on personal health needs.12345Why are researchers excited about this trial?
Researchers are excited about the use of vagal nerve stimulation (VNS) for gastric motor functions because it offers a novel approach to treating conditions like medication-resistant depression by potentially impacting the digestive system. Unlike typical treatments that might focus on balancing neurotransmitters with medication, VNS targets the vagus nerve, which plays a crucial role in regulating gut movement and accommodating food. This method could provide a dual benefit: addressing depression while also enhancing digestive processes, which could be a game-changer for individuals who haven't found relief through standard treatments.
What evidence suggests that vagal nerve stimulation is effective for gastric motor functions?
Research has shown that stimulating the vagus nerve (VNS) might improve stomach function, particularly in emptying food and stretching to accommodate it. Studies have found that VNS can speed up food passage by relaxing the pyloric sphincter, the valve at the stomach's exit. In animal studies, VNS resulted in quicker stomach emptying, suggesting similar effects in humans. This trial will examine the effects of VNS on gastric motor functions, specifically measuring gastric emptying and accommodation in participants treated with VNS for medication-resistant depression. Early results suggest VNS might enhance the stomach's ability to handle food, but further research is needed for confirmation.14567
Who Is on the Research Team?
Michael Camilleri, M.D., D.Sc.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults over 18 with drug-resistant epilepsy and disabling seizures, who are not candidates for resective surgery. Participants must be medically stable apart from epilepsy, able to attend study visits, and use birth control if applicable. Excluded are those recently in other trials or hospitalized for psychiatric conditions, on certain medications like anticoagulants or immunosuppressants, weigh over 350 pounds, can't eat eggs (used in tests), have substance abuse history or vocal cord paralysis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Assessment
Participants undergo combined gastric emptying/accommodation test prior to VNS implantation
Post-surgery Assessment
Participants undergo a second identical gastric emptying/accommodation test approximately 3 months after VNS activation
Follow-up
Participants are monitored for safety and effectiveness after the post-surgery assessment
What Are the Treatments Tested in This Trial?
Interventions
- Vagal Nerve Stimulant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
University of Minnesota
Collaborator