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Patients with acute disorders of consciousness receiving TMS-EEG for Consciousness Disorders

N/A
Waitlist Available
Led By Brian L. Edlow, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post injury
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disability Rating Scale (DRS) total score
Presence of consciousness as defined by a composite reference standard for consciousness that combines behavior, task-based EEG, and task-based fMRI

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with acute disorders of consciousness receiving TMS-EEGExperimental Treatment1 Intervention
Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post-injury.

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Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,362 Previous Clinical Trials
650,630 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,601 Total Patients Enrolled
8 Trials studying Consciousness Disorders
303 Patients Enrolled for Consciousness Disorders
Brian L. Edlow, MDPrincipal InvestigatorMassachusetts General Hospital
~80 spots leftby Aug 2029