Effect Of Vagal Nerve Stimulation On Gastric Motor Functions

Overview

About this study

The specific aim of this study is to compare simultaneous assessment of gastric emptying and gastric accommodation in response to the same caloric meal before and three months after activation of left cervical VNS.  Our hypothesis is that cervical VNS increases gastric accommodation and accelerates gastric emptying.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Drug Resistant Epilepsy with Seizures:

  • Subject must be at least 18 years old.
  • Subject must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
  • Disabling seizures (Disabling seizures are those with significant negative impact on the patient’s life).
  • Drug Resistant Epilepsy, with continuing seizures despite adequate trials of at least 2 appropriate anti-seizure drugs (ASDS) with therapeutic serum concentrations (as per the International League Against Epilepsy (ILAE) Commission on Therapeutic Strategies).
  • Not a good candidate for resective surgery as determined by our institution’s multidisciplinary epilepsy surgery committee.
  • Apart from epilepsy, subject should be medically and neurologically stable.
  • Subject is able to complete regular office visits and telephone appointments including the 2 imaging sessions in accordance with the study protocol requirements.
  • Subject is a male or non-pregnant female adequately protected from conception, or willing to use an acceptable method of birth control over the entire study duration if of childbearing potential.
  • Subject has been informed of his or her eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option.

Exclusion Criteria - Drug Resistant Epilepsy with Seizures:

 

  • Subject currently uses or during the study is expected to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.       
  • Subject has a substance abuse history (alcohol, prescription, or illicit medications) within the preceding two years.
  • Subject participated in another drug or device trial within the preceding 30 days (other than the REVEAL main CSP).
  • Subject has been hospitalized for a psychiatric condition within the preceding two years or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).
  • Subject has experienced unprovoked status epilepticus in the preceding year.
  • Subject is on anticoagulants and is unable to discontinue them peri-surgically, as required by the neurosurgeon or Investigator.
  • Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate). If platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the Investigator, and the neurosurgeon judge it to be advisable.
  • Subject with vocal cord paralysis.
  • Any other factor that may impact participant safety or compliance as per PI.
  •  Subject cannot speaks and reads English.

Eligibility last updated 6/14/23.  Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D., D.Sc.

Open for enrollment

Contact information:

Karla Crockett

5075384880

crockett.karla@mayo.edu

More information

Publications

Publications are currently not available