Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
This study is looking at new ways to understand consciousness in people with severe brain injuries in the intensive care unit (ICU). It uses a tool called Transcranial Magnetic Stimulation-Electroencephalography (TMS-EEG) along with other tests like behavioral assessments and brain imaging (functional electroencephalography and functional brain imagery). The goal is to see if TMS-EEG can accurately detect signs of consciousness and predict how well someone will recover after six months. You might be able to join if you are 18 or older, were independent before your brain injury, and had a brain injury within the last 28 days that caused a disorder of consciousness. The study aims to enroll 120 participants.
- Study design
- This is an interventional study that plans to enroll 120 participants. The phase of the study is not specified.
- What's involved
- You would undergo repeated behavioral assessments, task-based electroencephalography (EEG), and TMS-EEG. Conventional brain magnetic resonance imaging (MRI) and task-based functional MRI are optional.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your recovery will be assessed at 6 months after your injury.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
At a glance
Conditions
NCT06568536
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Massachusetts General Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
UW Health University Hospital
Madison, Wisconsinno site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Brian L. Edlow, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Presence of consciousness as defined by a composite reference standard for consciousness that combines behavior, task-based EEG, and task-based fMRI48 hours after the end of the TMS-EEG assessment
Behavioral assessments of consciousness (up to 5): The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level. The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input. The total score ranges between 0 (worst) and 23 (best). The CRSR-FAST assesses only those CRS-R behaviors that differentiate conscious (i.e., MCS) from unconscious (i.e., coma/VS) patients. Functional assessments of covert consciousness: A participant is classified as being conscious on task-based EEG if the probability with which the classifier distinguished task from rest conditions is p \< 0.05 and the accuracy value that indicates the classifier's performance is ≥ 60%. A participant is classified as being conscious on task-based fMRI if there is one statistical activation within a pre-specified region of interest.
- Disability Rating Scale (DRS) total score6 months post injury
The Disability Rating Scale (DRS) provides quantitative information regarding functional disability in patients recovering from severe brain injury. The total score on the DRS ranges from 0 to 29 with higher scores indicating a greater degree of disability. DRS subscale scores include eye opening \[score range 0-3\], communication \[score range 0-4\], motor response \[score range 0-5\], cognitive ability for feeding \[score range 0-3\], cognitive ability for toileting \[score range 0-3\], cognitive ability for grooming \[score range 0-3\], level of function \[score range 0-5\], and employability \[score range 0-3\]. Subscale scores are summed to produce the total score.