Probing Language Processes Using Transcranial Magnetic Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Accuracy on language task performance
研究概览
简要总结
This study will examine the effect of TMS on people with stroke and aphasia as well as healthy individuals.
详细描述
To examine the brain's structure and specific language function and interactive relationships, investigators will implement repetitive or rapid TMS protocols in an active (or sham)-controlled, within-subject, randomized studies. Aims will evaluate the effects of short-term changes on each of the semantic or phonological language process of interest in isolation and changes in the interaction between language sub-processes and their interaction with other cognitive domains that directly or indirectly affect language functions. The brain targets for TMS application will be informed by existing evidence on (correlational but not causal) associations between language regions and specific language processes from numerous prior neuroimaging (e.g., functional magnetic resonance imaging or fMRI) and neuropsychological studies. Healthy individuals and/or stroke survivors with aphasia will be recruited to address these aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and outcomes assessor will both be blinded to intervention modalities.
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
- 是
入选标准
- •Diagnosed with left hemisphere stroke
- •Consent date >= 1 month after stroke onset
- •Right-handed
- •Fluent in English
- •18 years of age or older
排除标准
- •Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
- •Non-decisional per decisionality questionnaire or other clinical assessment
- •Presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease)
- •A chronic medical condition that is not treated or is unstable
- •Presence of
- •cardiac stimulators or pacemakers or intracardiac lines
- •neurostimulators
- •medication infusion device
- •any other implants near the scalp (e.g., cochlear implants) or in the eye
- •metal in the body
- •Pregnancy
- •History of skull fractures, or skin diseases
- •History of ongoing or unmanaged seizures or a family history of epilepsy
- •Presence of factors that potentially decrease seizure thresholds
- •On pro-convulsant medications
- •Untreated Sleep deprivation or insomnia
- •Ongoing alcoholism or illegal drug abuse (e.g., cocaine or MDMA users)
- •History of dyslexia or other developmental learning disabilities
研究组 & 干预措施
Control TMS
Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans will be used for delivering active repetitive or rapid TMS to the control site.
干预措施: Transcranial Magnetic Stimulation (Device)
Sham TMS
Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans will be used for delivering sham repetitive or rapid TMS to the control or target site.
干预措施: Transcranial Magnetic Stimulation (Device)
Active TMS
Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans (also known as an air-cooled coil) will be used for delivering active repetitive or rapid TMS to the target site.
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Accuracy on language task performance
时间窗: Language tasks administered immediately before and/or after TMS administration (same day).
Improvement on language task performance as measured by increase in accuracy.
Reaction time on language task performance
时间窗: Language tasks administered immediately before and/or after TMS administration (same day).
Improvement on language task performance as measured by decrease in reaction time.
次要结局
未报告次要终点
研究者
Priyanka Shah-Basak, PhD
Assistant Professor
Medical College of Wisconsin