An observational study in Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness and Coma, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University of California, Los Angeles · Observational
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:
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:
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.
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.
During fNIRS monitoring, participants are exposed to a series of paradigms designed to engage different levels of sensory and cognitive processing. These include somatosensory stimulation, auditory processing tasks, semantic language processing, spatial navigation imagery, and motor imagery. Tasks are presented in a block design with alternating task and rest periods to allow detection of hemodynamic changes associated with neural activation.
The goal of this pilot study is to determine whether bedside fNIRS monitoring can produce reliable hemodynamic signals during these paradigms and whether the protocol can be feasibly implemented in a Neuro-ICU environment. Findings from this study will provide preliminary data to inform future research on objective methods for assessing brain activity in patients with DoC.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's planned enrollment of 55 is below the median of 100 across 58 observational studies indexed under Coma.
Browse Coma studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Compared within Coma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Consciousness Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population includes two groups: healthy adult volunteers and patients with DoC admitted to the neuro-intensive care unit. Healthy participants will be recruited from the local community and university population to establish baseline fNIRS responses during sensory and cognitive paradigms. Patients with DoC will be recruited from the Neuro-ICU at the participating medical center and include individuals with impaired consciousness following acute brain injury who meet the study eligibility criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy Control Participants:
DoC Patients:
Exclusion Criteria:
Healthy Control Participants:
DoC Patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Functional Near-Infrared Spectroscopy Monitoring
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.
Other: Functional Near-Infrared Spectroscopy Monitoring
Participants undergo functional near-infrared spectroscopy (fNIRS) monitoring while exposed to a structured series of passive sensory stimuli and guided mental tasks designed to engage different levels of cognitive processing. Paradigms include somatosensory stimulation, auditory processing, semantic language processing, spatial navigation imagery, and motor imagery. Hemodynamic responses are measured as changes in oxygenated and deoxygenated hemoglobin.
Task-evoked cortical hemodynamic response measured with functional near-infrared spectroscopy (fNIRS)
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.
Time frame: During a single fNIRS recording session (approximately 20-48 minutes, depending on participant group)
Plan to share: Undecided — A data sharing plan has not yet been finalized. De-identified IPD may be retained for future research for up to 5 years, consistent with the study consent form and in accordance with applicable regulations.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
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