Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

NCT05664854 | Recruiting

• 5 other identifiers: 2752763OT2OD02654514758322/LO/0463Z6364106/2022/03/39
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Electrical Impedance Tomography; Selective Vagus Nerve Stimulation; Vagus Nerve; Electrophysiology; Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Primary Outcome - Map of organ-specific functional activity in the cervical vagus nerve

  The cross-sectional map of organ-specific fascicles within the cervical vagus, indicating the location of pulmonary, cardiac, and recurrent laryngeal fascicles. The response in the appropriate organ(s) along with the imaging of the fascicles within the cervical vagus nerve and the degree of accordance of this with the fascicular map will be the primary outcomes.

  Within the first 3 years

Secondary Outcomes (1)

• Secondary Outcome - Optimised neurostimulation parameters

  Within the first 4 years

Study Arms (1)

sVNS and EIT of cervical vagus nerve

EXPERIMENTAL

Selective vagus nerve stimulation (sVNS) with a spatially selective vagal nerve cuff with physiological readouts such as electrocardiogram (ECG), heart rate, end-tidal carbon dioxide (EtCO2), respiratory rate, laryngeal electromyogram (EMG), etc., and electrical impedance tomography (EIT) recordings of the nerve.

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

Interventions

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

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.

sVNS and EIT of cervical vagus nerve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Written informed consent by patient or proxy
• Clinical diagnosis of disorder affected directly or indirectly or will possibly respond to vagus nerve stimulation

You may not qualify if:

• Aged 17 and below
• Unfortunately, it is unlikely that interpreters of all languages will be available in the unit so persons who cannot understand verbal explanation in English and for whom we could not find a suitable consultee would have to be excluded from the study.

Sponsors & Collaborators

• University College, London: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

National Hospital of Neurology and Neurosurgery

London, Greater London, WC1N 3BG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vagus Nerve Diseases; Epilepsy

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Study Officials

• Kirill Aristovich

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirill Aristovich

CONTACT

+44 (0) 20 3549 5035; k.aristovich@ucl.ac.uk

David Holder

CONTACT

+44 (0) 20 7679 0225; d.holder@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 27, 2022
• Study Start: December 4, 2023
• Primary Completion: January 31, 2025
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

GB (1)