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NCT06568536 · ClinicalTrials.gov registry record · NA
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
A NA study of Consciousness Disorders, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT06568536: Recruiting NA study of Consciousness Disorders, sponsored by Massachusetts General Hospital.
NCT06568536 is a NA study of Consciousness Disorders that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 120 participants, above the 33-participant average among 4 other Consciousness Disorders trials with a reported enrollment target (264% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06568536, a NA study of Consciousness Disorders, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study Summary
Disorders of consciousness (DoC) caused by severe brain injury affect millions of people worldwide each year. A patient's level of consciousness in the intensive care unit (ICU) significantly impacts the recovery from disability and is a primary determinant of family decisions about withdrawal of life-sustaining therapy (WLST). However, reliable assessment of consciousness in the ICU remains elusive. Transcranial magnetic stimulation-electroencephalography (TMS-EEG) is a tool that has shown the best performance in detecting signs of consciousness in patients with chronic DoC. The goals of this prospective, observational study are to demonstrate the diagnostic performance and prognostic utility of TMS-EEG in the ICU setting.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Wisconsin
- UW Health University Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-11-08 |
| Est. Completion | 2029-08-01 |
| Phase | NA |
What NCT06568536 shows while recruiting
NCT06568536 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 33-participant average among 4 other Consciousness Disorders trials with a reported enrollment target (264% higher).
The record links to 1 condition, with Consciousness Disorders appearing as the primary indexed condition, and to 1 intervention - of which Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG is the first listed.
NCT06568536 reports a single indexed study location in Massachusetts, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06568536 about?
NCT06568536 is a clinical study titled "Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU". Disorders of consciousness (DoC) caused by severe brain injury affect millions of people worldwide each year. A patient's level of consciousness in the intensive care unit (ICU) significantly impacts the recovery from disability and is a primary determinant of family decisions about withdrawal of li...
What is the current status of trial NCT06568536?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2024-11-08. Estimated completion is 2029-08-01.
What conditions does trial NCT06568536 study?
This clinical trial studies the following conditions: Consciousness Disorders.
What interventions are being tested in trial NCT06568536?
The interventions under investigation include: Repeated behavioral assessments, functional electroencephalography and brain imagery, TMS-EEG (OTHER).
Who is sponsoring clinical trial NCT06568536?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06568536 being conducted?
This trial has 2 study locations across Massachusetts, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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