Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- EEG power spectrum
研究概览
简要总结
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.
详细描述
OBJECTIVE:
To investigate whether the gross electrical activity of the outer ear canal contains the hippocampal theta rhythm (theta) - a potential biomarker for anxiety - and to identify potential modulatory effects that theta may have on vestibular signals, using electrovestibulography (EVestG).
STUDY POPULATION:
Forty-two (42) individuals, aged between 18 and 40 years, who report no psychological treatment in the past year.
The means of recruiting participants will conform with University of Manitoba Research Ethics Board guidelines. All participants will provide written, informed consent prior to participation. Additional consent for the drug experiment will be provided by a physician on the research team who will also write prescriptions for the study drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females who are between 18 and 40 years of age.
排除标准
- •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 CYP2D
- •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.
研究组 & 干预措施
Buspirone
Participants will receive buspirone 10 mg prior to experiments.
干预措施: Buspirone 10 Mg Oral Tablet (Drug)
Triazolam
Participants will receive triazolam 0.25 mg prior to experiments.
干预措施: Triazolam 0.25 MG Oral Tablet (Drug)
Placebo
Participants will receive a placebo prior to experiments.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
EEG power spectrum
时间窗: 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.
4-12 Hz modulation
时间窗: Derived from EEGs recorded for 30-45 mins.
4-12 Hz modulation of field potentials recorded in outer ear canal.
次要结局
- Signal correlations(Derived from EEGs recorded for 30-45 mins)
研究者
Zeinab Dastgheib
Principal Investigator
University of Manitoba