Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: sVNS and EIT of cervical vagus nerveExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Within the first 3 years

Secondary outcomes

1

Secondary Outcome - Optimised neurostimulation parameters

Achieved parameters of the neurostimulation such that measured biomarker effect for seizure suppression matches or exceeds that of a whole-nerve stimulation with conventional device, while side effects (heart rate change, pressure, respiratory reflexes, and laryngeal activity) are significantly decreased. The performance of selective stim VS existing technique is assessed with binary metric: success/no success. The success criteria is: The therapeutic biomarker is not significantly different from the existing technique, while there is a significant reduction in one of the biomarkers indicating the side effects. The exact therapeutic biomarker will be identified during execution of the first objective. The biomarkers indicating side effects: significant bradycardia, apnoea, laryngeal contraction, gastric motility. The effect is calculated as a % change of the measured physiological parameter during stimulation with respect to the baseline (no stimulation).

Time frame
Within the first 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

National Institutes of Health (NIH)

Collaborator