fNIRS for Disorders of Consciousness

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older

Proficient in English language

Intact cognition

Montreal Cognitive Assessment (MoCA) score > 26

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Functional Near-Infrared Spectroscopy Monitoring

    Other intervention

    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.

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Healthy Control Participants1 intervention
Group B: Patients with Disorders of Consciousness1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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