fNIRS for Disorders of Consciousness

NCT07485361 | Recruiting

• 1 other identifier: 24-000789
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Disorders of Consciousness Due to Severe Brain Injury; Disorders of Consciousness; Coma; Minimally Conscious State; Unresponsive Wakefulness Syndrome; Brain Injury; TBI Traumatic Brain Injury

Keywords

Functional Near-Infrared Spectroscopy; Neurocritical Care; Functional Neuroimaging; Neuro Intensive Care Unit; Neurovascular Coupling; Consciousness Assessment

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

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.

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.

Other: Functional Near-Infrared Spectroscopy Monitoring

Interventions

Functional Near-Infrared Spectroscopy Monitoring OTHER

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.

Healthy Control Participants; Patients with Disorders of Consciousness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA School of Nursing; Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders; Coma; Persistent Vegetative State; Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Unconsciousness; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Lauren H Furtick, MSN, RN, PhD Candidate

CONTACT

(424)281-0121; lfurtick@ucla.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)