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Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03954483
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Information provided by (Responsible Party):
Cory Bosecke, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Buspirone 10 Mg Oral Tablet Drug: Triazolam 0.25 MG Oral Tablet Drug: Placebo oral tablet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Buspirone
Participants will receive buspirone 10 mg prior to experiments.
Drug: Buspirone 10 Mg Oral Tablet
Orally administered prior to experiments.

Experimental: Triazolam
Participants will receive triazolam 0.25 mg prior to experiments.
Drug: Triazolam 0.25 MG Oral Tablet
Orally administered prior to experiments.

Placebo Comparator: Placebo
Participants will receive a placebo prior to experiments.
Drug: Placebo oral tablet
Orally administered prior to experiments.

Primary Outcome Measures :
  1. EEG power spectrum [ Time Frame: Derived from EEGs recorded for 30-45 mins ]
    4-12 Hz EEG power spectrum at F8 (10/20 international system) and in outer ear canal.

  2. 4-12 Hz modulation [ Time Frame: Derived from EEGs recorded for 30-45 mins. ]
    4-12 Hz modulation of field potentials recorded in outer ear canal.

Secondary Outcome Measures :
  1. Signal correlations [ Time Frame: Derived from EEGs recorded for 30-45 mins ]
    4-12 Hz correlations between F8 (10/20 international system) and outer ear canal activity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

• Male and female university students who are between 18 and 25 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03954483

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Contact: Cory Bosecke, BSc 204-294-8432
Contact: Brian Lithgow, MSc 204-478-6406

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Canada, Manitoba
Riverview Health Centre Not yet recruiting
Winnipeg, Manitoba, Canada, R3L2P4
Contact: Cory Bosecke, BSc         
Sponsors and Collaborators
University of Manitoba

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Responsible Party: Cory Bosecke, Principal Investigator, University of Manitoba Identifier: NCT03954483     History of Changes
Other Study ID Numbers: B2018:096
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data might be shared in the future.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
GABA Modulators
GABA Agents