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Nerve-Zapping device could speed up Post-Surgery waking, but study never started

NCT ID NCT07191340

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before any participants were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

Oct 2023

An estimate. Start dates often move.

Expected to finish

Nov 2023

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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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