State-dependent Entrainment of Intrinsic Brain Rhythms to Improve Interregional Functional Coupling.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of whole hand grip force precision
研究概览
简要总结
This pilot study aims at establishing personalized state-based rTMS for precision neurorehabilitation, we designed a within-subject cross-over study to test closed-loop repetitive transcranial magnetic stimulation and electroencephalography (rTMS-EEG) comparing the targeting of two key nodes in the frontoparietal network during bimanual visuomotor force tracking in persons with upper extremity sensorimotor impairment affecting eye-hand control.
详细描述
There is a need for oscillatory or repetitive neuromodulatory tools and methods that are effective in entraining intrinsic neural rhythms to improve inefficient functional coupling within neural circuits. The goal of the proposed study is to develop a closed-loop application of repetitive transcranial magnetic stimulation (rTMS) and electroencephalography (EEG) suitable for use in multidomain precision neural-circuit based rehabilitation studies that permits the time-locked application of rTMS pulses to the phase of the intrinsic neural oscillation (personalized state-based application) in a defined behavioral context (e.g., goal-directed eye-hand control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult volunteers (age ≥18 years)
- •right-hand dominance (defined with the Edinburg Handedness Scale)
- •voluntary whole-hand grip force (Medical Research Council scale for muscle force ≥2)
- •capable of repeated grasp and release with 5% of maximum voluntary contraction (standardized with an in-house computer-based assessment involving whole-hand grip force tracking upon visual cues with a digital dynamometer).
排除标准
- •presence of any MRI risk factors (such as an electrically, magnetically, mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, any other electrically sensitive support system, or claustrophobia)
- •presence of any contraindications to repetitive transcranial magnetic stimulation, rTMS (e.g., history of seizures or epileptic activity, currently taking medications that lower seizure thresholds)
- •any neurological or psychiatric disorders affecting cognitive function (e.g., established dementia) affecting the ability to understand the purpose of the study and give informed consent or ability to complete cognitive testing
- •substance use disorder
- •visual impairment that precludes completion of scanner tasks
- •uncontrolled hypertension despite treatment
- •intake of tricyclic anti-depressants
- •musculoskeletal disorders affecting bimanual grasp- and release
- •pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). If the participant is a woman of childbearing potential, a urine pregnancy test will be performed on a standard basis.
- •severe aphasia affecting particularly of receptive nature (NIH Stroke Scale, NIHSS Language subsection ≥2) affecting the ability to understand the purpose of the study and give informed consent
- •pregnancy
研究组 & 干预措施
state-dependent repetitive transcranial magnetic stimulation (rTMS)
Repetitive TMS will be applied to cortical targets based on task-based (visuomotor) brain activation.
干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)
结局指标
主要结局
Change of whole hand grip force precision
时间窗: 90 minutes
Force time series will be used to extract two measures for each trial to describe distinct features of visuomotor force adjustment: 1) Root Mean Square Error (RMSE) to characterize the deviation of the actual force from the target force, i.e., over- and undershoot and 2) sample entropy (SmpEn) to quantify the randomness or uncertainty of the sampled force time series. From these measures, the trial-based relative changes in RMSE and SmpEn from baseline (before intervention) will be computed.
Change of functional brain connectivity.
时间窗: 90 minutes
Trial-specific phase-based connectivity will be extracted from the electroencephalography (EEG) time series and computed relative to baseline (before intervention).
次要结局
未报告次要终点
研究者
Kirstin-Friederike Heise
Assistant Professor-Faculty
Medical University of South Carolina