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临床试验/NCT07485361
NCT07485361招募中不适用

Functional Near-infrared Spectroscopy in Disorders of Consciousness: Protocol Testing and Pilot in Neuro-ICU Setting

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
Task-evoked cortical hemodynamic response measured with functional near-infrared spectroscopy (fNIRS)

研究概览

简要总结

The goal of this observational study is to learn whether functional near-infrared spectroscopy (fNIRS) can measure brain activity in healthy adults and in people with disorders of consciousness (DoC) in the neuro-intensive care unit (Neuro-ICU). DoC include conditions such as coma and minimally conscious state that occur after severe brain injury. These conditions make it difficult to assess a person's level of awareness because many clinical tests rely on observable behaviors such as speaking or moving, which are commonly impaired after brain injury.

The main questions the study aims to answer are:

  • Can fNIRS detect changes in brain activity in healthy adults when they receive sensory stimulation or perform mental tasks?
  • Can the same fNIRS protocol be used in patients with disorders of consciousness in the Neuro-ICU to measure brain responses and determine whether the method is feasible in this clinical setting?

The investigators will first study healthy adult volunteers to establish baseline brain responses and determine which tasks produce the most reliable signals. The protocol will then be applied to patients with disorders of consciousness admitted to the Neuro-ICU.

Participants will take part in a single research session lasting about 30 to 45 minutes while wearing the lightweight fNIRS headband that measures brain oxygen levels using near-infrared light. During the session, participants will:

  • Wear a non-invasive fNIRS headband placed on the forehead
  • Receive gentle sensory stimulation (for example, compression devices on the legs or hands)
  • Listen to sounds or spoken sentences
  • Perform guided mental tasks such as imagining walking through their home or imagining moving a limb

The study does not test a treatment and will not change medical care. The goal is to determine whether fNIRS can safely and reliably measure brain activity at the bedside and provide preliminary information that may help guide future research on improving the assessment of consciousness after brain injury.

详细描述

Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging method that measures changes in oxygenated (HbO) and deoxygenated hemoglobin (HbR) in cortical tissue. Through neurovascular coupling, neural activity in specific brain regions is associated with increased metabolic demand and localized changes in cerebral blood flow, resulting in measurable shifts in HbO and HbR concentrations. These changes form the basis of the blood oxygen level-dependent (BOLD) signal measured in functional magnetic resonance imaging (fMRI) and the optical signals detected by fNIRS.

Assessing level of consciousness in patients with severe brain injury remains a clinical challenge. Standard bedside assessments rely primarily on observable behaviors such as eye movements, motor responses, or verbal output. When these behaviors are impaired by brain injury, observable behavior may not accurately represent preserved cognition. Functional neuroimaging studies have demonstrated that some individuals diagnosed with disorders of consciousness (DoC) can generate brain responses during cognitive tasks even when behavioral responses are absent. However, many neuroimaging methods, particularly fMRI, are difficult to implement in critically ill patients because they require specialized facilities and patient transport outside the intensive care unit. fNIRS provides a portable, bedside method for measuring hemodynamic responses associated with neural activity, making it potentially suitable for use in the neuro-intensive care unit.

This study is a non-therapeutic observational pilot investigation designed to evaluate fNIRS signal responses and the feasibility of implementing a structured cognitive paradigm during bedside monitoring. The study is conducted in two stages.

In the first stage, the protocol is implemented in healthy adult participants to characterize the magnitude and consistency of fNIRS responses during a series of sensory and cognitive paradigms. These data establish baseline response patterns and help identify task conditions that produce reliable hemodynamic signals.

In the second stage, the refined protocol is implemented in patients with DoC in the neuro-intensive care unit to evaluate feasibility and obtain preliminary observations of cortical hemodynamic responses in this population.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy Control Participants:
  • Age 18 years or older
  • Proficient in English language
  • Intact cognition
  • Montreal Cognitive Assessment (MoCA) score > 26
  • DoC Patients:
  • Age 18 years or older
  • Proficient in English language
  • Surrogate decision maker available
  • Admission to the intensive care unit within 28 days
  • Documented Glasgow Coma Scale (GCS) score
  • Auditory Function subscale score ≥1 on the Coma Recovery Scale-Revised (CRS-R)

排除标准

  • Healthy Control Participants:
  • Known baseline hearing impairment without available hearing aids
  • Neurological or psychiatric history
  • DoC Patients:
  • Known baseline hearing impairment without available hearing aids
  • Inability to obtain informed consent
  • Extensive bilateral frontal injury on available imaging (CT/MRI)
  • Patients who have undergone craniectomy surgery
  • IV sedation in the past 24 hours
  • Absent auditory startle response (<1 from Auditory Function subscale score of CRS-R)

研究组 & 干预措施

Patients with Disorders of Consciousness

Patients with disorders of consciousness (DoC) admitted to the neuro-intensive care unit undergo functional near-infrared spectroscopy (fNIRS) monitoring using the refined paradigm to evaluate feasibility and obtain preliminary observations of cortical hemodynamic responses in this population.

干预措施: Functional Near-Infrared Spectroscopy Monitoring (Other)

Healthy Control Participants

Healthy adult participants undergo functional near-infrared spectroscopy (fNIRS) monitoring during a series of sensory and cognitive paradigms to characterize baseline hemodynamic responses and establish reference patterns in individuals with intact cognition.

干预措施: Functional Near-Infrared Spectroscopy Monitoring (Other)

结局指标

主要结局

Task-evoked cortical hemodynamic response measured with functional near-infrared spectroscopy (fNIRS)

时间窗: During a single fNIRS recording session (approximately 20-48 minutes, depending on participant group)

Cortical hemodynamic responses measured using fNIRS, quantified as changes in oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) during somatosensory and cognitive task paradigms relative to rest periods.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Furtick, MSN, RN

Principal Investigator

University of California, Los Angeles

研究点 (1)

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