VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-60
SponsorUniversity of Louisville
About this trial
Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery. The mechanism of action is not well understood; however it is increasingly recognized that electrical stimulation of the vagus nerve may impact other organ systems in the body including the immune and gastrointestinal systems. Concrete characterization of the peripheral effects of VNS in human gut microbiome and immune systems will: (1) elucidate peripheral mechanism of action of chronic VNS therapy, (2) identify peripheral preoperative biomarker of VNS efficacy, and (3) create a foundation for research investigating new GM and IM-related disease indications for VNS.
The primary objective of this study is to characterize the pre- and post-operative oral and gut microbiome of patients implanted with vagal nerve stimulator (VNS) for epilepsy. Secondary objectives of this study include: (1) to characterize the pre-operative and post-operative immune profile of patients undergoing VNS implantation for epilepsy, (2) to elucidate whether oral and/or gut microbiota changes are related to VNS efficacy for epilepsy and (3) identification of a biomarker predicting VNS efficacy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing VNS implantation for the first time as a treatment for epilepsy and
Documented follow up with a Louisville-based neurologist in the past 1 year. If at the University of Utah or Baylor University documented ability to travel to their corresponding neurologist.
Documented ability to travel to Louisville for outpatient medical care. If at the University of Utah or Baylor University documented ability to travel to their facilities.
Disqualifiers
Previous treatment with VNS (other than the one implanted for this study)
Current pregnancy (contraindication to surgery)
Active infection
History of cancer or treatment with chemotherapy
Trial design
Design model
Single group
Treatments tested in this trial
Vagal nerve stimulation (VNS)
DeviceImplantation with vagal nerve stimulator for epilepsy
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients undergoing device implantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Metagenomic microbiome profile
Stool and saliva specimens will be used to generate metagenomic profiles of gut flora populations. Pre- and post-VNS gut profiles will be compared. It is important to note that the genomic profile of all gut flora is the outcome, rather than the presence or absence of any specific type of bacteria.
Time frame
1 year2
Bowel movement frequency
A brief clinical questionnaire regarding the frequency and consistency of bowel movements will be administered. This will be done pre- and post-VNS implantation in each patient. Any medications to manage diarrhea and constipation will be carefully recorded as well as their efficacy.
Time frame
1 year3
Bowel habits
A clinical bowel habits questionnaire will be administered at each study visit to determine changes in bowel habits pre and post operatively. Additionally, the Bristol stool scale will be assessed at each visit.
Time frame
1 year4
Immune Profile 1 - Flow cytometric profiling of cell populations
One milliliter of whole blood from each subject will be aliquoted into separate tube and directly stained with fluorochrome-conjugated antibodies to investigate the cellular composition of the blood. Subtypes of lymphocytes, monocytes and granulocytes will be defined by set phenotypic marker expression
Time frame
1 yearSecondary outcomes
1
Epilepsy severity
Patients will keep a log of seizure type, keeping careful track of the frequency of each type, how long each seizure lasts and what medical interventions are taken to stop each seizure. Additionally, 1 year Engel outcome will be assessed.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov