MedTrace Logo

Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

NCT05664854 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-09

No results posted yet for this study

Summary

Electroceuticals is a new field in which the goal is to treat a wide variety of medical diseases with electrical stimulation of autonomic nerves. A prime target for intervention is the cervical vagus nerve as it is easily surgically accessible and supplies many organs in the neck, thorax and abdomen. It would be desirable to stimulate selectively in order to avoid the off-target effects that currently occur. This has not been tried in the past, both because of limitations in available technology but also because, surprisingly, the fascicular organisation of the cervical vagus nerve is almost completely unknown. The aim of this research is to investigate the functional anatomy of fascicles in the cervical vagus nerve of humans. This will include defining innervation to the heart, lungs and recurrent laryngeal and, if possible, the oesophagus, stomach, pancreas, liver and gastrointestinal tract. It will be achieved by defining fascicle somatotopic functional anatomy with spatially-selective vagus nerve stimulation (sVNS) and the new method of fast neural imaging with Electrical Impedance Tomography (EIT). EIT is a novel imaging method in which reconstructed tomographic images of resistance changes related to the opening of ion channels over milliseconds can be produced using rings or arrays of external electrodes. In humans, using a nonpenetrating nerve cuff with sVNS or fast neural EIT, this will be performed for 30 minutes transiently during an operation to insert a vagal nerve stimulator for treatment of epilepsy and deliver images in response to activity such as respiration or the electrocardiogram (ECG).

Conditions

  • Vagus Nerve Diseases
  • Epilepsy
  • Vagus Nerve Autonomic Disorder

Interventions

DEVICE

Nerve cuff electrodes for spatially selective vagus nerve stimulation and electrical impedance tomography

Vagus nerve electrode cuffs will be placed on the exposed human vagus nerve during routine vagal nerve stimulator implantation surgery. These cuffs will then be used for spatially selective vagus nerve stimulation, with physiological readout, and electrical impedance tomography for the functional imaging of organ-specific regions in the nerve at cervical level.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University College, London

    lead OTHER

Principal Investigators

  • Kirill Aristovich · University College, London

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2025-01-31
Completion
2027-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664854 on ClinicalTrials.gov