Prognostication of Recovery in Early Disorders of Consciousness Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
By collecting multimodal metrics (e.g., clinical factors, neuroimaging, and EEG) in the early phase of severe brain injury (i.e., during the acute hospitalization when a patient has impaired consciousness), and measuring the patients' recovery of consciousness, function, and quality of life in the late phase (at 6 months following the brain injury), we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute brain injury (including ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, encephalitis)
Inability to follow commands, speak intelligibly, or communicate (i.e., diagnosis of coma, vegetative state, or minimally conscious state minus) due to the underlying brain injury and within 28 days of the brain injury
Age 18 or greater.
Disqualifiers
Subjects will be excluded if they do not speak English (given the reliance on verbal questionnaires conducted in English) or if they regain the ability to follow commands, speak intelligibly or communicate (i.e., improves to minimally conscious state plus or greater) before they undergo MRI or EEG.
Trial population
Disorders of consciousness following acute brain injury
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Diagnostic testMRI will include structural sequences (e.g., T1 weighted imaging, T2 weighted imaging, T2 FLAIR, diffusion weighted imaging with apparent diffusion coefficient, susceptibility weighted imaging, and diffusion tensor imaging). Using the structural sequences we will make note of the types of brain lesions (e.g., ischemic stroke, hemorrhage, hypoxic-ischemic brain injury), and the locations of these brain lesions. MRI will also include fMRI under three conditions: while the patient is at rest (to evaluate resting state functional connectivity), while the patient is exposed to auditory stimuli (to evaluate passive fMRI responses to stimuli), and while the patient is asked to follow commands (to evaluate active fMRI responses to tasks).
EEG
Diagnostic testThe EEG will include resting, stimulus-based, and task-based assessments of brain function.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients with disorders of consciousness2 interventions
Trial outcomes
Primary outcomes
1
Glasgow Outcome Scale-Extended
Metric of neurologic function. The minimum score is 1, and the maximum score is 8. Higher scores represent less disability (8 represents non-disabling symptoms, 1 represents death).
Time frame
6 months following enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: