NCT03953768: VNS-IG

VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems

Recruiting now NA Last updated 25 November 2024

What this trial tests

NA trial testing Vagal nerve stimulation (VNS) in Autoimmune Diseases in 30 participants. Currently enrolling.

Timeline

1 April 2021

Primary endpoint
13 December 2025

31 December 2026

Quick facts

Lead sponsor	University of Louisville
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	1 April 2021
Primary completion	13 December 2025
Estimated completion	31 December 2026
Sites	4 locations across United States

Drugs / interventions tested

• Vagal nerve stimulation (VNS)

Conditions studied

• Autoimmune Diseases — all drugs for Autoimmune Diseases →
• Epilepsy — all drugs for Epilepsy →
• Autonomic Dysfunction — all drugs for Autonomic Dysfunction →
• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

University of Louisville

Who can join

Adults 0 to 60, any sex, with Autoimmune Diseases or Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of the Cholinergic Anti-Inflammatory Reflex in Central Nervous System Diseases.
   Ramos-Martínez IE, Rodríguez MC, Cerbón M, Ramos-Martínez JC, et al · · 2021 · cited 26× · PMID 34948222 · DOI 10.3390/ijms222413427
2. Cholinergic immunomodulation in inflammatory bowel diseases.
   Serafini MA, Paz AH, Nunes NS. · · 2022 · cited 16× · PMID 34977822 · DOI 10.1016/j.bbih.2021.100401
3. Macrophages as central mediators of sympathetic neuro-immune interplay in autoimmunity.
   Muntjewerff EM, Josyula VS, Lehmair F, Christoffersson G. · · 2025 · PMID 41476959 · DOI 10.3389/fimmu.2025.1654382