Biomarkers of Thalamic LIFUP in Chronic Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Positron Emission Tomography
研究概览
简要总结
When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.
详细描述
In the present study, we propose taking the "next step" to assess whether LIFUP can affect objective and validated markers of DoC patient impairment (in the direction of lesser impairment). Specifically, patients will be admitted at Casa Colina Hospital for a 10-day (in-patient) protocol, and two follow-up sessions, conducted remotely (e.g., over the phone) at 7 and 30-days post-discharge. The full length of the study is 40 days from admission. Over the admission period, patients will undergo multiple measurements of validated biomarkers, including behavioral testing, brain metabolism (using Positron Emission Tomography), and electroencephalography, before and after one session of LIFUP to thalamus.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of VS or MCS based on the CRS-R .
- •Chronic status:
- •3 months post-injury for non-traumatic etiologies
- •12 months post-injury for traumatic etiology
- •18 years of age or older.
- •If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol.
排除标准
- •History of neurological disorder (other than the brain injury).
- •Unsuitability to undergo Magnetic Resonance (MR) assessment (e.g., non-MR compatible implants).
- •Unsuitability to undergo LIFUP neuromodulation (e.g., presence of non-bone implant or absence of bone under the expected positioning of the device by the left temporal bone window).
- •Manifest continuous spontaneous movement (which would prevent imaging)
- •Participation in another concurrent clinical trial.
- •Having undergone PET, CT, or other exam involving the use of ionizing radiation in the 12 months prior to the date of scheduled admission to Casa Colina.
- •Dependence on ventilator.
研究组 & 干预措施
Treatment LIFUP
LIFUP will be performed at the bedside using frameless stereotaxy. Specifically, the LIFUP transducer will be fit to the patient's head employing adjustable straps, and will be positioned over the patient's left temporal bone to minimize bone absorption and refraction. Accurate aiming will be ensured using the Brain Sight neuronavigation device, customized for tracking our LIFUP transducer. Following LIFUP, the patient will undergo a second EEG session, except for the EEG cap being fit to the patient's head prior to the LIFUP session so that, as soon as LIFUP administration is complete, the EEG paradigm can be promptly administered. The patient will then be allowed to rest (~1h).The patient will then be administered a second dose of tracer in order to undergo a second PET measurement. Finally, at the end-of-day, the clinical coordinator will collect an Adverse Event Questionnaire and will fit the PSG device for night monitoring.
干预措施: BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation (Device)
结局指标
主要结局
Positron Emission Tomography
时间窗: This will be conducted on Day 4.
Assess change in local standard uptake value (SUV) and global SUV.
Polysomnography
时间窗: This will be conducted Day 1-10 of the study.
Change in nightly average density of sleep-spindles and sleep structure.
Coma Recovery Scale-Revised
时间窗: Coma recovery scale-revised is completed at enrollment and twice a day on Day 1-10, except for Day 4. Maximum score is 23 with a minimum of 0. Higher scores mean better outcome.
Change in maximum total and subscale scores.
Electroencephalography
时间窗: The EEG will be conducted at Day 3, 4, 7 and 10 of the study.
Change in fast to slow frequency power spectrum density and in P3b amplitude.
次要结局
未报告次要终点
研究者
Caroline Schnakers
Assistant Director of Research
Casa Colina Hospital and Centers for Healthcare