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NCT05664854: EITsVNS

Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

Recruiting now NA Last updated 9 August 2024
What this trial tests

NA trial testing Nerve cuff electrodes for spatially selective vagus nerve stimulation and electrical impedance tomography in Vagus Nerve Diseases in 50 participants. Currently enrolling.

Timeline
4 December 2023
Primary endpoint
31 January 2025
31 January 2027

Quick facts

Lead sponsorUniversity College, London
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment50
Start date4 December 2023
Primary completion31 January 2025
Estimated completion31 January 2027
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University College, London

Who can join

18 and older, any sex, with Vagus Nerve Diseases or Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University College, London trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05664854.

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