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RECRUITINGINTERVENTIONAL

Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Age over 18 - Written willing to sign a consent form by patient or proxy - Clinical diagnosis of disorder affected directly or indirectly or will possibly respond to vagus nerve stimulation Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Treatments Being Tested

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.

Locations (1)

National Hospital of Neurology and Neurosurgery
London, Greater London, United Kingdom