Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials (TMS-EEG)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- 1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity)
研究概览
简要总结
Patients evaluated at Penn Presbyterian Medical Center for traumatic brain injury (TBI), who sign the informed consent, will undergo assessment of electrophysiologic potentials evoked by transcranial magnetic stimulation (TMS), using the Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Traumatic Brain Injury (Acute, Subacute, Chronic) group:
- •Age 18 years and older
- •Evidence of mechanical energy impacting the head or inertial forces affecting the head
- •Either (A) or (B):
- •Trauma-related abnormality on CT scan on admission
- •If CT normal, documented/verified TBI based on evidence of either loss of consciousness, post-traumatic amnesia, confusion, or post-traumatic symptoms.
排除标准
- •for Traumatic Brain Injury (Acute, Subacute, Chronic) group:
- •History of disabling pre-existing neurologic disease (Such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
- •History of premorbid disabling condition that interfere with outcome assessments
- •Bilaterally absent pupillary responses
- •Penetrating traumatic brain injury
- •Prisoners or patients in police custody
- •Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil/probe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments).
- •Inclusion Criteria for Healthy Control group:
- •Age 18 years and older
- •No history of TBI in the past 12 months
- •Exclusion Criteria for Healthy Control group:
- •History of disabling pre-existing neurologic disease (Such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
- •History of premorbid disabling condition that interfere with outcome assessments
- •Prisoners or patients in police custody
- •Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil/probe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments).
研究组 & 干预措施
Healthy Control
干预措施: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel) (Device)
Traumatic Brain Injury (Acute, Subacute, Chronic)
干预措施: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel) (Device)
结局指标
主要结局
1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity)
时间窗: Day 1
1. WFA (Waveform Adherence) 2. STP (short-term plasticity) 3. EPD (Early Phase Deflection) 4. LPD (Late Phase Deflection) 5. Connectivity (these are all in arbitrary units)
2. Correlate DELPHI-MD outputs with neural deficits identified through patient reported and clinician reported outcome measures
时间窗: Day 1
For single timepoint (day 1).
次要结局
未报告次要终点
研究者
Ramon Diaz-Arrastia
Presidential Professor & Director of Clinical Traumatic Brain Injury Research Initiative, University of Pennsylvania Perelman School of Medicine
University of Pennsylvania