Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal
This study aims to discover a new, non-invasive method for detecting the brain activity involved in anxiety. Researchers believe that a particular brain rhythm, called theta, which is known to play a role in anxiety, might be measurable from tiny signals in the outer ear canal using a new technology called EVestG. Currently, measuring this rhythm is difficult and invasive. If successful, this research could lead to a simple way to continuously monitor anxiety levels, helping doctors to better understand and diagnose anxiety disorders. This study will involve healthy volunteers taking different medications or a placebo to see how these ear signals change.
At a glance
What is this study about?
Imagine being able to check your anxiety levels with a simple device placed in your ear. That's what scientists are hoping to achieve with this study. They are looking into a new technology that can pick up certain electrical signals from your outer ear canal. They believe these signals might reflect a specific pattern of brain activity, called the 'theta rhythm,' which is known to be linked to anxiety.
Currently, measuring this theta rhythm is very difficult and is usually only done in a hospital setting for specific medical reasons, like in some epilepsy patients. This new, non-invasive (meaning it doesn't involve needles or surgery) technology could change that, offering a way to check anxiety levels more easily and even throughout a normal day. This could lead to earlier and more accurate diagnosis of anxiety disorders.
To test this idea, researchers will give healthy volunteers either a medicine known to affect the theta rhythm or a dummy pill (placebo). By observing how the ear signals change after taking the medicine, they hope to confirm that these ear signals are indeed reflecting the theta rhythm and its connection to anxiety. This is a crucial step towards developing new tools to help people with anxiety.
Key takeaways
- New study exploring non-invasive anxiety measurement.
- Investigating brain signals (theta rhythm) from the outer ear.
- Potential for easier and continuous anxiety monitoring.
- Single visit, 2-3 hour commitment.
- Participation involves taking a study pill (drug or placebo).
Who may be eligible?
If you're thinking about taking part, you need to be a man or woman between the ages of 18 and 40. You shouldn't have received any psychological treatment or taken any psychiatric medication in the last year.
There are several reasons why you might not be able to join. For example, if you're pregnant or breastfeeding, or if you have certain medical conditions like heart, lung, kidney, or liver disease, diabetes, or a history of neurological problems. Also, if you're left-handed or colour-blind, or have certain allergies, you wouldn't be able to participate.
The researchers will also check if you have any ear canal skin issues, major hearing loss, balance problems, or if you've recently had the flu or COVID-19. They'll also make sure any other medications or natural remedies you're taking won't interfere with the study drugs.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 40 years old?
- Have you *not* had any psychological treatment or taken psychiatric drugs in the last year?
- Do you *not* have a history of major medical conditions (like heart, kidney, or neurological diseases)?
- Are you *not* pregnant or breastfeeding?
- Are you *not* currently unwell with flu-like symptoms, COVID-19, or recovering from a recent injury/operation?
- Are you *not* left-handed or colour-blind?
What does participation involve?
If you decide to join this study, you'll visit the Riverview Health Centre for about 2-3 hours. First, a doctor on the research team will explain everything and get your consent to participate, including for the drug part of the study. You'll then be randomly assigned to one of three groups: one group will receive a 10mg Buspirone tablet, another will get a 0.25mg Triazolam tablet, and the third group will receive a placebo (a dummy pill).
During your visit, you'll have electrodes placed in your outer ear canal and on your forehead to record brain activity. You'll then take part in two short experiments: one involving whole-body movements and another called a "Stop Signal Task." You'll also complete some questionnaires about your mood, thinking skills, tiredness, and balance, and have your hearing and balance checked. There's no ongoing follow-up after this single visit.
Potential risks and benefits
Locations (1)
- Riverview Health CentreVerified postcodeWinnipeg, Canada· Recruiting
Common questions
What is the main goal of this study?
The goal is to find out if specific brain signals linked to anxiety can be measured easily and non-invasively from the outer ear canal.
What is a 'theta rhythm'?
It's a particular pattern of electrical activity in the brain that is known to be involved in anxiety.
Will I know if I'm getting a real drug or a placebo?
No, this is a 'double-blind' study, meaning neither you nor the researchers will know which pill you receive until the study is over.
How long will my involvement last?
Your participation will involve a single visit to the research centre, lasting approximately 2-3 hours.
Is this study suitable for someone already being treated for anxiety?
No, participants must not have received psychological treatment or taken psychiatric medication in the past year.
How to find out more
Zeinab A Dastgheib, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.