Transauricular Vagus Nerve Stimulation for Delirium

Overseen By Charles Mikell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stony Brook University

Disqualifiers: Severe neurologic disability, Pacemaker, Epilepsy, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a device that sends gentle electrical pulses to a nerve in the ear (transauricular vagus nerve stimulation) can safely assist patients with delirium, a common state of confusion in very sick or injured hospitalized patients. The study will assess whether ICU patients can tolerate this treatment and its effects on brain activity and oxygen levels. Participants will undergo two daily sessions, each lasting about 30 minutes, for up to seven days. Right-handed ICU patients with delirium who do not have certain medical conditions, such as pacemakers, may be eligible to join. The main goal is to determine if this new approach is safe and practical for future use. As an unphased trial, this study offers patients the chance to contribute to pioneering research that could lead to innovative treatments for delirium.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems that participants will continue their usual hospital care for delirium while receiving the new treatment.

What prior data suggests that this device is safe for patients with delirium?

Research has shown that transauricular vagus nerve stimulation (taVNS) is generally safe and well-tolerated. In earlier studies, some participants experienced mild side effects, such as a tingling or prickly sensation in the ear or slight redness on the skin where the device was applied. These effects are usually temporary and not serious.

Other studies have found that taVNS can be safely used in various situations. For instance, research involving surgical patients showed it to be safe, with few problems reported. This suggests that taVNS can be safely used in hospitals, even for patients with delirium.

While serious side effects are rare, clinical trial participants are closely monitored to ensure their safety, allowing for early identification of potential issues. Overall, taVNS appears to be a safe option for many people, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for delirium focus on managing symptoms with medications like antipsychotics or sedatives. However, transauricular vagus nerve stimulation (taVNS) offers a new approach by directly targeting the nervous system. Unlike traditional drugs that can have significant side effects, taVNS is a non-invasive technique that stimulates the vagus nerve through the ear. Researchers are excited about taVNS because it has the potential to quickly reduce delirium symptoms without the risks associated with medications.

What evidence suggests that this device is effective for delirium?

Research has shown that stimulating the vagus nerve through the ear, known as transauricular vagus nerve stimulation (taVNS), might help with delirium by influencing brain signals and oxygen levels. Early studies suggest that taVNS can alter brain activity in a way that may benefit delirium. For instance, researchers have examined its potential to reduce the severity of delirium after surgery, showing promise in easing symptoms. Although more research is needed to fully understand its effectiveness, these initial studies provide a foundation for its use in delirium treatment. In this trial, participants will receive taVNS alongside standard clinical management to evaluate its potential benefits for delirium. ^{1 2 3 4 5}

Who Is on the Research Team?

Isadora Botwinick, MD

Principal Investigator

Stony Brook University Hospital

Are You a Good Fit for This Trial?

This trial is for right-handed adults in the ICU diagnosed with delirium. It's not suitable for those with recent brain bleeds, strokes, pacemakers, or other conditions that make it unsafe to participate.

Inclusion Criteria

I am over 22 years old and admitted to Stony Brook University Hospital.

Right-handed

Screen positive for delirium on CAM-ICU instrument

Exclusion Criteria

I weigh less than 40kg.

I have pain or have had an injury to my face or ear.

I am currently on a breathing machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive taVNS treatment using a small clip electrode placed on the ear, twice per day for up to 7 days

7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transauricular Vagus Nerve Stimulation

Trial Overview

The study tests if transauricular vagus nerve stimulation (taVNS), a non-invasive device delivering electrical pulses to the ear nerve, is safe and feasible for ICU patients with delirium. All participants will receive taVNS alongside standard care.

How Is the Trial Designed?

Group I: TaVNS and Usual Care for Delirium Experimental Treatment 1 Intervention

Hospitalized, right-hand-dominant adults (age ≥ 22) with delirium, receive transauricular vagus nerve stimulation (taVNS) in addition to standard clinical management. TaVNS is administered twice a day, for a maximum of 7 days, until delirium resolves or the patient is discharged from the ICU.

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07258082?locStr=United+States&country=United+States

Study Details | NCT07258082 | TaVNS for Delirium

This will be a single-arm, open-label trial to assess the brain blood oxygen saturation and EEG of hospitalized patients with delirium, and to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11973790/

'Transauricular vagus nerve stimulation' for prevention of ...

This study aims to assess the effectiveness and safety of transauricular VNS (ta-VNS) in preventing POD in elderly patients undergoing major surgery.

3.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/2/e092413

Effects of transcutaneous auricular vagus nerve stimulation ...

POD is associated with poor outcomes, including increased postoperative complications, prolonged hospitalisation, high costs and increased perioperative ...

4.

anzctr.org.au

anzctr.org.au/Trial/Registration/TrialReview.aspx?id=389803

ANZCTR - Registration

efficacy of TrAnsauricular Vagal Nerve Stimulation to reduce postoperative delirium severity: a double-blind randomised, sham-controlled ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06421077

Transcutaneous Auricular Vagus Nerve Stimulation ...

Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause ...