Disorders of Consciousness Due to Severe Brain InjuryNCT07485361
fNIRS for Disorders of Consciousness
An observational study of Disorders of Consciousness Due to Severe Brain Injury and Disorders of Consciousness, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness, Coma
- What is being tested?
- Functional Near-Infrared Spectroscopy Monitoring
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Healthy Control Participants:
- Age 18 years or older
- Proficient in English language
- Intact cognition
- Montreal Cognitive Assessment (MoCA) score > 26
- DoC Patients:
Show all 12Show fewer
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA School of Nursing; Ronald Reagan Medical Center
Los Angeles, California, 90095
About this study
Official title: Functional Near-infrared Spectroscopy in Disorders of Consciousness: Protocol Testing and Pilot in Neuro-ICU Setting
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness, Coma, Minimally Conscious State, Unresponsive Wakefulness Syndrome, Brain Injury
- Being tested
- Functional Near-Infrared Spectroscopy Monitoring
- Keywords
- Functional Near-Infrared Spectroscopy, Neurocritical Care, Functional Neuroimaging, Neuro Intensive Care Unit, Neurovascular Coupling, Consciousness Assessment
- Medical subject headings
- Consciousness Disorders, Coma, Persistent Vegetative State, Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Near-Infrared Spectroscopy MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional Near-Infrared Spectroscopy Monitoring | |
| 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. Receives: Other: Functional Near-Infrared Spectroscopy Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During a single fNIRS recording session (approximately 20-48 minutes, depending on participant group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Consciousness Due to Severe Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Furtick, MSN, RN, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485361
- Sponsor's protocol ID
- 24-000789
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Near-infrared Spectroscopy in Disorders of Consciousness: Protocol Testing and Pilot in Neuro-ICU Setting
- ClinicalTrials.gov ID
- NCT07485361
- Acronym / sponsor ID
- 24-000789
- Conditions
- Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness, Coma, Minimally Conscious State, Unresponsive Wakefulness Syndrome, Brain Injury
- Keywords
- Functional Near-Infrared Spectroscopy, Neurocritical Care, Functional Neuroimaging, Neuro Intensive Care Unit, Neurovascular Coupling, Consciousness Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Participants | – | Other: Functional Near-Infrared Spectroscopy MonitoringHealthy 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. |
| Patients with Disorders of Consciousness | – | Other: Functional Near-Infrared Spectroscopy MonitoringPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- Age 18 years or older
- Proficient in English language
- Intact cognition
- Montreal Cognitive Assessment (MoCA) score > 26
- Age 18 years or older
Key exclusion criteria (10 listed)
- Known baseline hearing impairment without available hearing aids
- Neurological or psychiatric history
- Known baseline hearing impairment without available hearing aids
- Inability to obtain informed consent
- Extensive bilateral frontal injury on available imaging (CT/MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Near-Infrared Spectroscopy MonitoringParticipants 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. | Other | Healthy Control Participants, Patients with Disorders of Consciousness |
Primary outcome
Task-evoked cortical hemodynamic response measured with functional near-infrared spectroscopy (fNIRS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness Due to Severe Brain Injury and Disorders of Consciousness, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren H Furtick, MSN, RN, PhD Candidate ((424)281-0121, lfurtick@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task-evoked cortical hemodynamic response measured with functional near-infrared spectroscopy (fNIRS) (time frame: During a single fNIRS recording session (approximately 20-48 minutes, depending on participant group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.