Recruiting

fNIRS Evaluation

Sponsor:

UCLA

Code:

NCT07485361

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Disorders of Consciousness

Coma

Minimally Conscious State

Unresponsive Wakefulness Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Functional Near-Infrared Spectroscopy Monitoring

Study Details

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

Study ID

NCT07485361

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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 and Locations

Central contacts

Lauren H Furtick, MSN, RN, PhD Candidate

(424)281-0121lfurtick@ucla.edu

Locations

UCLA School of Nursing; Ronald Reagan Medical Center

Recruiting

Los Angeles, California, United States, 90095

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-06-08.