fNIRS for Disorders of Consciousness (NCT07485361) | Clinical Trial Compass
RecruitingNot Applicable
fNIRS for Disorders of Consciousness
United States55 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses fNIRS to measure brain activity in people with disorders of consciousness — could you explain what that scan actually involves for my family member, and whether it requires them to do anything or just lie still?
2Since this is listed as Phase NA, which often means it's a non-interventional or observational study, does participating in this trial change my loved one's treatment in any way, or is it purely about measuring brain responses?
3The trial is measuring something called a 'task-evoked cortical hemodynamic response' — what does that mean in practical terms, and what would the research team learn about my family member's level of consciousness from this test?
4Given that my loved one's diagnosis could fall under coma, minimally conscious state, or unresponsive wakefulness syndrome, does their specific diagnosis affect whether this study might be relevant to their care, or how the results would be interpreted?
5Are there any standard clinical assessments for disorders of consciousness that you would recommend we pursue first, and how does participating in this research study fit alongside those existing diagnostic options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Task-evoked cortical hemodynamic response measured with functional near-infrared spectroscopy (fNIRS)
Timeframe: During a single fNIRS recording session (approximately 20-48 minutes, depending on participant group)