fNIRS for Disorders of Consciousness

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT07485361
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
55 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA School of Nursing; Ronald Reagan Medical CenterLos AngelesCalifornia90095-

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By research site
UCLA School of Nursing; Ronald Reagan Medical Center· Los Angeles, CA

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