Exploring Markers of Brain Health With EEG and TMS: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Correlation of DELPHI-MD Output Measures with the online BrainHealth Index
研究概览
简要总结
The combination of transcranial magnetic stimulation (TMS) and electroencephalography (EEG) has been suggested as a promising brain imaging tool for identifying biomarkers of brain health.
In this pilot study, study investigators will explore the neurophysiological metrics of brain health with a non-invasive brain imaging technique, alongside behavioral and fMRI metrics collected through another study (NCT04869111).
详细描述
The Direct Electro-Physiological Imaging medical device (Delphi-MD), developed by QuantalX Neuroscience, combines both TMS and EEG technologies. This is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in participants, and the EEG device records brain electrophysiological response to the stimulation.
Recruitment for this pilot study will be restricted to participants in the imaging cohort of a separate study, The BrainHealth Project (NCT04869111). As that cohort is already completing behavioral and fMRI metrics, this exploratory study would allow study investigators to examine relevant associations between those metrics with the neurophysiological metrics from the Delphi device.
Study participants will complete two in-person sessions with the Delphi-MD device that align with their pre-scheduled imaging appointments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be an active brain imaging participant in The BrainHealth Project (NCT04869111)
- •Minimum age of 22
- •Fluent in English
- •Able to read & hear information over a computer
- •Must pass an MRI safety screener to assess the presence of contraindicators for MRI compatibility (i.e., non-removable metal within/on the body, claustrophobia, pregnancy, non-correctable vision problems, head trauma, and CNS disease)or other standard requirements as determined by the Imaging Center.
- •Must pass a modified TMS Adult Safety Screen
- •Meet all criteria for study as determined by the study physician
排除标准
- •A diagnosis of a neurodegenerative disease
- •A history of stroke, concussion, or brain injury that currently hinders them from functioning at their prior level
- •A diagnosis of autism spectrum disorder that currently hinders them from functioning independently.
- •Metallic brain implants or fragments (like a shunt, pacemaker, clips, coils, bullet fragments, cochlear implants)
- •Magnetically activated implants or electronically implanted devices
- •Medication pumps
- •Personal or family history of epilepsy, seizure(s), seizure disorder.
- •History of, or risk factors for syncope (fainting)
- •Report significant cognitive challenges
- •Report untreated health issues (like substance abuse, hypertension, hypo- or hyper-thyroidism)
- •Have claustrophobia
结局指标
主要结局
Correlation of DELPHI-MD Output Measures with the online BrainHealth Index
时间窗: Up to one year
Evaluate the strength and significance of correlations between DELPHI-MD output metrics (e.g., cortical excitability, local/global mean field potentials, response amplitude, and latency) and scores from the BrainHealth Index. Unit of Measurement: Correlation coefficient (r). (Minimum value: -1.0, Maximum value: 1.0) (Higher value represents stronger correlation)
次要结局
- Correlation of DELPHI-MD Output Measures with Quantitative fMRI Metrics(Up to one year)
研究者
Sandra Chapman, PhD
Professor, Chief Director of UTD Center for BrainHealth
The University of Texas at Dallas