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Disorders of Consciousness clinical trials

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NCT ID: NCT05463029 Active, not recruiting - Clinical trials for Disorders of Consciousness

Resting State fMRI in Disorders of Consciousness

Start date: August 1, 2022
Phase:
Study type: Observational

Disorders of consciousness (DoC) remain a major clinical challenge in which high rates of misdiagnosis and difficult prognostication stem from limitations in the ability to access the disordered physiological processes mechanisms of coma in real world clinical settings. There is a great need to develop, validate, and translate to clinical use reliable diagnostics to detect brain recovery potential not evident on neurobehavioral assessment. While resting state fMRI (rs-fMRI) has demonstrated potential to improve the diagnostic evaluation of DoC by detecting features of consciousness that are occult at bedside evaluation, this technology has yet to achieve widespread clinical utility. The investigators propose that recent advancements in rs-fMRI capabilities can be combined with streamlined analysis and interpretation approaches to overcome persistent intensive care unit to perform rs-fMRI in patients with prolonged impaired consciousness due to several causes including TBI, cardiac arrest, stroke, seizures, and severe CNS infection. The investigators will determine the optimal methods of data acquisition, analysis and interpretation for predicting recovery of consciousness in these patients. Our expectations are that this approach will produce highly reliable functional connectomic characterization of individual DoC patients, thereby allowing for more accurate outcome prediction. The investigators will additionally investigate the utility of a novel, simplified radiological approach to rs-fMRI data interpretation in comparison to computationally intensive connectomic approaches. This exploratory/developmental project is expected to provide critical data needed to design and appropriately power future R01 studies validating the efficacy of fMRI-based network integrity in the clinical evaluation of DoC.