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fNIRS for Disorders of Consciousness

NCT07485361 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2026-03-24

No results posted yet for this study

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
  • Brain Injury
  • TBI Traumatic Brain Injury

Interventions

OTHER

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485361 on ClinicalTrials.gov