14-113 Nemoto: NSI PEMF Biomarker Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- CSF and serum biomarkers
研究概览
简要总结
Pulsed Electromagnetic Field (PEMF) Reduction of CSF and Serum Biomarkers After Traumatic Brain Injury (TBI).
The primary objective of this pilot study is to determine whether PEMF treatment (PEMF+) reduces the magnitude and duration of the increase in CSF and blood biomarkers after traumatic brain injury (TBI) compared to a PEMF untreated (PEMF-) group. Values in both groups are compared to uninjured brain CSF and blood biomarker levels obtained from hydrocephalus patients undergoing ventriculo-peritoneal shunt placement. A secondary objective of this pilot study is to determine whether PEMF treatment improves the physiologic status of the brain as evaluated by brain tissue monitors of thermal dilution cerebral blood flow (CBF), intracranial pressure (ICP), and tissue PO2 (PbtO2). Improved physiologic status would be reflected by increased CBF, PbtO2, and reduced ICP. Improved physiologic status may also be inferred from derived variables reflecting improved cerebrovascular and intracranial pressure autoregulation.
A tertiary objective of this pilot study is to obtain preliminary data on the relationship between the time course and magnitude of post-TBI CSF and blood biomarker levels as they relate to three month outcome by Glasgow outcome score extended (GOSE) and modified Rankin Score (mRS).
详细描述
Investigators will enroll a total of 45 subjects, 30 after TBI and 15 patients with hydrocephalus having ventriculo-peritoneal shunts inserted. It is anticipated that in order to enroll 30 TBI participants investigators will need to screen approximately 50 subjects; and for the patients undergoing ventriculo-peritoneal shunt placement we will need to screen 30 patients in order to enroll 15. Of the 30 TBI patients, 15 will have PEMF+ and 15 will have PEMF-. PEMF+ means that the device will be in place and will be on, PEMF- means that the device will be in place but will not be turned on.
The study will be double blinded. The honest broker (HB) Dr. Amal Alchbli, will not be involved in the study except to turn on the PEMF device with the indicator light showing when the PEMF device is on , will be hidden from view by tape. The HB will keep a list of the patients treated with PEMF+ or not PEMF- along with their MRN# coded and the start and end times of PEMF treatment during their stay in the NSI. The nurses in the unit will be asked to indicate on the CNS monitor when the PEMF applicators are on or off the patient.
The subjects will participate in this study for up to one week while in the Neuroscience Intensive Care Unit (NSI). There will also be follow up on secondary clinical outcome measures at discharge, one and three months post discharge. The one and three month follow ups will be conducted over the phone.
The duration of enrollment is expected to be two years. The estimated date for the investigators to complete this study (complete primary analyses) is 3.0 years.
The estimated time for data retention is 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Honest broker will determine and record PEMF+ and PEMF- treated patients keeping investigator team blinded as to treatment until data analysis has been completed.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old GCS <9 Male or Female Placement of multimodality monitoring Hummingbird device or an External Ventricular Drain as part of clinical treatment/care.
- •Multimodality monitoring as part of clinical treatment/care
排除标准
- •Pregnant Vulnerable population: Prisoners, No legally authorized representative (LAR). Patients with implanted metallic leads. Implants include cardiac pacemakers/defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators and other nerve stimulators.
- •Patients without multimodality monitoring or an EVD/Hummingbird Device
结局指标
主要结局
CSF and serum biomarkers
时间窗: CSF and serum collection from Zero to 7 days after injury
CSF and serum biomarkers: Magnitude of increase and rate of decrease in patients treated with SofPulse active and Sofpulse inactive and both compared to CSF and serum biomarkers in control normal pressure hydrocephalus.
次要结局
- Glasgow Outcome Score Extended(Admission, daily for 7 days, discharge from hospital and one and three months)
- Glasgow Coma Score(Admission, daily for 7 days, discharge from hospital and one and three months)
- Modified Rankin Scale(Admission, daily for 7 days, discharge from hospital and one and three months)
研究者
Edwin Nemoto
Research Professor
University of New Mexico