Electrical Impedance Tomography Imaging of Functional Anatomy and Selective Stimulation of Fascicles Within the Vagus Nerve

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
National Hospital of Neurology and Neurosurgery
RECRUITING
London
Contact Information
Primary
Kirill Aristovich
k.aristovich@ucl.ac.uk
+44 (0) 20 3549 5035
Backup
David Holder
d.holder@ucl.ac.uk
+44 (0) 20 7679 0225
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 50
Treatments
Experimental: sVNS and EIT of cervical vagus nerve
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.
Related Therapeutic Areas
Sponsors
Leads: University College, London
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov