Measuring brain activity related to anxiety through the ear canal

Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

This study is testing if a new way to measure brain activity through the ear can help understand anxiety levels in young adults who haven't had therapy recently.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: University of Manitoba (Academic / other)
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT03954483 on ClinicalTrials.gov

What this trial studies

This study investigates the potential of using electrovestibulography (EVestG) to measure hippocampal theta rhythm, which may serve as a biomarker for anxiety disorders. It involves 42 participants aged 18 to 40 who have not received psychological treatment in the past year. Participants will be randomly assigned to receive either triazolam, buspirone, or a placebo before undergoing two experimental tasks while their brain activity is recorded from the outer ear canal. The goal is to explore the relationship between theta rhythm and anxiety levels in a non-invasive manner.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 40 with no recent psychological treatment.

Not a fit: Patients with a history of neurological illness, substance use disorders, or those currently on psychiatric medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a continuous, non-invasive method for diagnosing anxiety disorders.

How similar studies have performed: While the use of EVestG is relatively novel, similar approaches in measuring brain activity have shown promise in other contexts.

Eligibility criteria

Inclusion Criteria:

• Males and females who are between 18 and 40 years of age.

Exclusion Criteria:

* Psychological treatment in the past year or taking any psychiatric drug.
* Drugs that interact with the study drugs or that have anxiolytic/anxiogenic properties.
* Antibiotics or natural health products that inhibit/induce CYP3A4 or CYP2D6.
* History of substance use disorder or family history of substance use disorder.
* Pregnancy (or breastfeeding), left handedness, or colour blindness.
* Individuals who have a current diagnosis, or history of, a neurological illness.
* A history of stroke, head injury, loss of consciousness, epilepsy.
* Kidney or liver disease/impairment.
* COPD or sleep apnea.
* Skin lesions involving the ear canal, self-reported or as assessed in examination at the lab.
* Any unknown balance disorders, as assessed by investigator via balance test.
* Major hearing loss, self-reported or as assessed by investigator via audiogram.
* Allergic skin reactions to chemical agents including detergents.
* Heart disease, lung disease or diabetes.
* Influenza, Covid-19, or flu-like symptoms.
* Recovering from an accident, injury, or operation.

Where this trial is running

Winnipeg, Manitoba

• Riverview Health Centre — Winnipeg, Manitoba, Canada (Recruiting)

Study contacts

• Study coordinator: Zeinab A Dastgheib, PhD

Conditions Anxiety