Nerve-Zapping device could speed up Post-Surgery waking, but study never started
NCT ID NCT07191340
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to test a noninvasive device that stimulates the vagus nerve through the skin to see if it could help people recover consciousness more quickly after anesthesia. The researchers wanted to enroll adults undergoing lumbar spine surgery and measure how fast they woke up, as well as whether the device reduced delirium and depression. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Oct 2023
An estimate. Start dates often move.
- Expected to finish
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Nov 2023
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged \> 18 years of age * Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels * Mini-Mental State Examination (MMSE) score ≥ 15-accept mild * Ability to use a keyboard * Able to understand and communicate in English * Be able to consent independently * Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study. * Must not be involved in any other research intervention study testing neurobehavioral functioning * Good internet connectivity and ability to use computer, smart phone or good telephone connectivity (follow up) Exclusion Criteria: * Age \< 18 years of age * History of vagotomy (cutting the vagus nerve) * History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and/or New York Heart Association symptoms * MMSE \< 15 * History of seizure disorder or intracranial hemorrhage * Patients with carotid stenosis * Patients with aneurysms * Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability * Pregnancy, breastfeeding * Active addiction history * ECG adhesive allergy * Severe aphasia, preventing subject from understanding the protocol and giving written consent * Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device * Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their neck * Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device * Patients with metallic device such as a stent, bone plate or bone screw implanted at or near their neck * Patients who are using another device at the same time (e.g., transcutaneous electrical nerve stimulation (TENS) Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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