MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in brain functional connectivity.
研究概览
简要总结
The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic subjective tinnitus measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.
详细描述
This is an investigator-initiated MRI study of High Definition (HD) transcranial electrical stimulation (tES) in adults with chronic subjective tinnitus. HDtES is a mild, noninvasive form of brain stimulation using small electrodes to target a small part of the brain/cortex. Primary outcomes are changes in brain function and connectivity measured with MRI before and after a single 20-minute session of HDtES. Secondary outcomes are changes in tinnitus symptoms after 20-minutes of HDtES on 5 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 18 and 75
- •Race/ethnicity: all races and ethnic groups
- •Sex/Gender: all
- •Capacity to provide informed consent
- •Subjective tinnitus symptoms confirmed by patient self report meeting the following criteria:
- •Present for at least one year prior to start of study
- •Present (can be heard when consciously attended to) >50% of awake time
- •Intrudes (is heard even when attempting to ignore/mask) >10% of awake time
- •Has discussed tinnitus symptoms with clinician (i.e., physician, audiologist) to confirm low/no likelihood of physical or neurological origin of tinnitus symptoms (e.g., acoustic neuroma, Meniere's Disease, etc.), confirmed by patient self-report
- •Stable standard or no pharmacological treatment regimen for tinnitus with no change in treatment 6 weeks prior to study start
排除标准
- •Ages below 18 (neurobiology is quite different in children vs. adults)
- •Ages above 75 (cortical excitability changes with age)
- •Tinnitus symptoms with known medial origin, including:
- •Meniere's disease
- •Pulsatile tinnitus
- •Acoustic neuroma
- •Spontaneous optoacoustic emissions
- •Any other known medical origin
- •Severe mood disorder (major depression or anxiety)
- •Diagnosis of any medical condition potentially affecting brain function, including:
- •neuropsychiatric or mental disorders (bipolar, post-traumatic stress disorder, etc.)
- •severe mood disorders (major depression or anxiety)
- •psychotic states or disorders
- •developmental disorders
- •neurological disorders, including mild cognitive impairment
- •significant head injury
- •significant history of alcohol/substance abuse or dependence
- •active chronic pain condition (>1 year duration)
- •other major medical conditions (e.g., cancer, stroke).
- •MRI contraindications:
- •metal or other implants that are not MR-safe
- •claustrophobia
- •pregnancy or suspected pregnancy
- •tDCS contraindications*:
- •skin conditions or injuries on the scalp
- •hair extensions, wigs, braids, etc. that cannot be removed prior to the study
- •metal implants or pacemakers (also contraindicated for MRI)
- •Non-English speakers (due to written consent and questionnaires administered)
- •Significant history of alcohol/substance abuse or dependence within last 12 months
- •Neurostimulation or neuromodulation treatment longer than 20 minutes within the past 3 months
- •Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, or anti-psychotics.
研究组 & 干预措施
Active
干预措施: Transcranial Direct Current Stimulation (Device)
Sham
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Changes in brain functional connectivity.
时间窗: immediate
Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z).
次要结局
- Changes in tinnitus symptoms(1 week, 2 weeks, 1 month)
研究者
Amber Leaver
Research Associate Professor
Northwestern University