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临床试验/NCT05018117
NCT05018117已完成1 期

Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

University of California, Berkeley1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
44
试验地点
1
主要终点
frequency tuning of excitatory auditory fMRI cortical responses

研究概览

简要总结

Nicotine enhances auditory-cognitive function because it mimics the brain's system for "paying attention" to important sounds amid distractions (for example, understanding speech in a noisy environment). In part, nicotine does this by activating inhibitory neurons in the auditory cortex. Since age-related hearing deficits result, in part, from the loss of inhibitory neurons in auditory cortex, this project will determine whether nicotine's effects can compensate for reduced inhibition in the aging auditory cortex and thereby restore auditory function.

The investigators will use functional magnetic resonance imaging (fMRI) to measure the selectivity of responses in auditory cortex to tones of various frequencies. The investigators will measure the effects of nicotine (administered as chewing gum) and aging on these fMRI response properties. The investigators hypothesize that frequency selectivity will decrease with aging and increase following nicotine administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency

排除标准

  • deafness or excessive hearing loss
  • smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
  • history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
  • regular use of prescription medications (excluding oral contraceptives)
  • drug dependency

研究组 & 干预措施

Young (18-28 years) participants - nicotine gum

Experimental

6 mg nicotine gum, one time before fMRI measurements

干预措施: Nicotine gum (Drug)

Old (60-85 years) participants - nicotine gum

Experimental

6 mg nicotine gum, one time before fMRI measurements

干预措施: Nicotine gum (Drug)

Young (18-28 years) participants - placebo gum

Placebo Comparator

placebo gum, one time before fMRI measurements

干预措施: Placebo gum (Other)

Old (60-85 years) participants - placebo gum

Placebo Comparator

placebo gum, one time before fMRI measurements

干预措施: Placebo gum (Other)

结局指标

主要结局

frequency tuning of excitatory auditory fMRI cortical responses

时间窗: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.

Functional magnetic resonance imaging (fMRI) responses to pure tone stimuli ranging from 88-8000 Hz will be recorded. For each voxel in objectively identified auditory cortical area, a tuning curve model will be fit to the data. One of the parameters of this model is the width of frequency tuning of excitatory responses, and this is the primary outcome measure.

次要结局

  • frequency tuning of inhibitory auditory fMRI cortical responses(Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.)
  • amplitude of excitatory auditory fMRI cortical responses(Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.)
  • amplitude of inhibitory auditory fMRI cortical responses(Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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