FUS of the Dentate Nucleus and Superior Cerebellar Peduncle of the Cerebellum Induces Changes to EEG Power Bands, Spatiotemporal Dynamics, and Cognitive Function in Healthy Humans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Electroencephalogram (EEG) power and spatiotemporal dynamics
研究概览
简要总结
The goal of this preclinical study is to assess the effects of focused ultrasound stimulation to the cerebellum on brain dynamics and cognition in healthy volunteers aged 18 to 40. The main questions it aims to answer are:
Does FUS applied to the cerebellum affect cognition?
Does FUS applied to the white matter or gray matter of the cerebellum with the same parameters result in different outcomes?
Researchers will compare active and sham stimulations.
Participants will be asked to complete cognitive tasks after receiving FUS to the cerebellum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Exclusion Criteria:
- •Participants must not have claustrophobia or anxiety regarding MRI scan.
- •Participants must not have current or planned pregnancy.
- •Participants must not have history of neurological or psychiatric disorder.
- •Participants must not have predisposition for fainting spells (syncope).
- •Participants must not have implanted material (e.g., pacemaker, neurostimulator, medication infusion device, cochlear implants).
- •Participants must not have medical patch that cannot or may not be taken off (e.g., nicotine patch).
- •Participants must not be currently taking psychoactive medication, or must have stopped taking such medication for at least 2 weeks before starting experiment (excluding contraception).
- •Participants must not have skin disease on or close to the scalp.
- •Participants must not have direct relatives (parents, siblings, children) with epilepsy, convulsion, or seizure.
- •Participants must abstain from the use of any recreational drugs in the 48-hour period prior to taking part in the experiment.
- •Participants must not consume more than 4 alcoholic units within the 24-hour period before participation.
排除标准
- 未提供
研究组 & 干预措施
Dentate
FUS parameters set to target dentate with pre-specified distance and intensity
干预措施: Focused ultrasound (Procedure)
Sham
FUS transducer is off, otherwise the process is the same
干预措施: Focused ultrasound (Procedure)
Sham
FUS transducer is off, otherwise the process is the same
干预措施: EEG (Diagnostic Test)
Dentate
FUS parameters set to target dentate with pre-specified distance and intensity
干预措施: EEG (Diagnostic Test)
Superior cerebellar peduncle
FUS parameters set to target superior cerebellar peduncle with pre-specified distance and intensity
干预措施: Focused ultrasound (Procedure)
Superior cerebellar peduncle
FUS parameters set to target superior cerebellar peduncle with pre-specified distance and intensity
干预措施: EEG (Diagnostic Test)
结局指标
主要结局
Electroencephalogram (EEG) power and spatiotemporal dynamics
时间窗: Through study completion, peri-procedurally, on days 1, 2 and 3
The investigators measure the changes in EEG power in delta, theta, alpha, beta and gamma band, and spatiotemporal dynamics while administering concurrent transcranial focused ultrasound stimulation (tFUS). The EEG will also be used to asses network changes during sonication.
Electrooculogram (EOG) power and spatiotemporal dynamics
时间窗: Through study completion, peri-procedurally, on days 1, 2 and 3
The investigators measure the ocular saccades from both frontal head electrodes and electrodes places by the sides of the eyes while administering concurrent tFUS. This data will be used for identifying and removing eye-movement artifacts from EEG and assess eye saccades during sonication. This will be applied to some of the participants but not all, due to availability.
次要结局
- Brief Ataxia Rating Scale (BARS)(Through study completion, post-procedurally, on days 1, 2 and 3)
- Cerebellar Cognitive Affective Syndrome Scale (CCASS)(Through study completion, post-procedurally, on days 1, 2 and 3)
- n-Back Continuous performance task(Through study completion, post-procedurally, on days 1, 2 and 3)
- Agency Task(Through study completion, post-procedurally, on days 1, 2 and 3)
- Verbal Paired Associates (VPA)(Through study completion, post-procedurally, on days 1, 2 and 3)
研究者
Mohammad Alkhawashki
Dr
University of Nottingham