Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

NCT03954483 | Recruiting

• 1 other identifier: B2018:096
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

New technologies are needed to help diagnose anxiety disorders. EVestG has facilitated the identification of numerous possible biomarkers of several psychiatric disorders. Some EVestG features seem to be caused by differences in low-frequency modulation that is consistent (both in frequency and behaviour) with the hippocampal rhythm (theta), which is known to play a role in anxiety. Critically, there is ample support in the literature for an anatomical and functional basis for the modulation of vestibular signals via theta. If anxiety could be measured continuously, perhaps throughout a patient's day, or throughout a task, it might be able to confirm an anxiety disorder. However, current techniques for measuring theta are highly invasive, performed rarely, and only in epilepsy patients. EVestG technology, however, is non-invasive, and could potentially record anxiety levels in any subject for extended periods of time. The proposed study will attempt to identify hippocampal theta in vestibular signals in healthy participants through a double-blind administration of two different drugs that are dissimilar both pharmacologically and in acute clinical effects but which are known to reduce the theta rhythm.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• EEG power spectrum

  4-12 Hz EEG power spectrum at F8 (10/20 international system) and in outer ear canal.

  Derived from EEGs recorded for 30-45 mins

• 4-12 Hz modulation

  4-12 Hz modulation of field potentials recorded in outer ear canal.

  Derived from EEGs recorded for 30-45 mins.

Secondary Outcomes (1)

• Signal correlations

  Derived from EEGs recorded for 30-45 mins

Study Arms (3)

Buspirone

EXPERIMENTAL

Participants will receive buspirone 10 mg prior to experiments.

Drug: Buspirone 10 Mg Oral Tablet

Triazolam

EXPERIMENTAL

Participants will receive triazolam 0.25 mg prior to experiments.

Drug: Triazolam 0.25 MG Oral Tablet

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo prior to experiments.

Drug: Placebo oral tablet

Interventions

Buspirone 10 Mg Oral Tablet DRUG

Orally administered prior to experiments.

Buspirone

Triazolam 0.25 MG Oral Tablet DRUG

Orally administered prior to experiments.

Triazolam

Placebo oral tablet DRUG

Orally administered prior to experiments.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Riverview Health Centre

Winnipeg, Manitoba, R3L2P4, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Buspirone; Tablets; Triazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Zeinab A Dastgheib, PhD

CONTACT

204-229-3923; Zeinab.Dastgheib@umanitoba.ca

Brian Lithgow, MSc

CONTACT

204-478-6406; Brian.Lithgow@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 17, 2019
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)