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New treatment option for Post Operative Delirium
Official title Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
ClinicalTrials.gov ID: NCT07610655
What this study is testing
- What it's testing
- This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged \> 18 years of age
- Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
- Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild
- Ability to use a keyboard
- Able to understand and communicate in English
You likely can't join if
- 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...
- MoCA \< 18
- History of seizure disorder or intracranial hemorrhage
- Patients with carotid stenosis
See the full eligibility criteria
- Aged \> 18 years of age
- Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels
- Montreal Cognitive Assessment (MoCA) score ≥ 18 - 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
- 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
- MoCA \< 18
- 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 will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.