| NCT ID | NCT07485361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Disorders of Consciousness Due to Severe Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2026-05-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07485361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disorders of Consciousness Due to Severe Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07485361 currently recruiting?
Yes, NCT07485361 is actively recruiting participants. Contact the research team at lfurtick@ucla.edu for enrollment information.
Where is the NCT07485361 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07485361 clinical trial?
NCT07485361 is sponsored by University of California, Los Angeles. The trial plans to enroll 55 participants.