Recruiting

EVestG

Sponsor:

University of Manitoba

Code:

NCT03954483

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Buspirone 10 Mg Oral Tablet

Triazolam 0.25 MG Oral Tablet

Placebo oral tablet

Study Details

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

Study ID

NCT03954483

Start date

Oct 16, 2023

Status verified date

Feb, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Buspirone

Participants will receive buspirone 10 mg prior to experiments.

experimental: Triazolam

Participants will receive triazolam 0.25 mg prior to experiments.

placebo comparator: Placebo

Participants will receive a placebo prior to experiments.

Interventions

Buspirone 10 Mg Oral Tablet

Orally administered prior to experiments.

Triazolam 0.25 MG Oral Tablet

Orally administered prior to experiments.

Placebo oral tablet

Orally administered prior to experiments.

Primary outcome measure

  • EEG power spectrum [ Time Frame: Derived from EEGs recorded for 30-45 mins ]
  • 4-12 Hz modulation [ Time Frame: Derived from EEGs recorded for 30-45 mins. ]

Central Contacts and Locations

Central contacts

Zeinab A Dastgheib, PhD

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

Brian Lithgow, MSc

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

Locations

Riverview Health Centre

Recruiting

Winnipeg, Manitoba, Canada, R3L2P4

More Information

Sponsor

University of Manitoba

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-02-18.