Study to Assess and Monitor Brain Activity

NCT ID: NCT04602988

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2025-08-31

Brief Summary

A mainstay in the diagnosis and care of hospitalized patients is the assessment of mental status. Changes in mental status can have broad clinical significance, and while some patients are admitted with mental status changes, nearly half of the patients who experience delirium in the hospital develop it after admission in a manner that is hard to predict on the level of individual patients. Patients with altered mental status such as delirium have worse clinical outcomes, suggesting that early monitoring of mental status can identify important clinical populations who may benefit from targeted delirium prevention and intervention. Delirium remains under-recognized in the hospital, in part due to its fluctuating nature. Typically, mental status is assessed sporadically, perhaps once a day, through intermittent and subjective clinical interactions. As such, there is a clear clinical need for objective, continuous methods to monitor mental status. Such methods could potentially improve detection of delirium, potentially even predicting it prior to clinical recognition, and therefore direct multimodal delirium prevention and intervention strategies when most effective-before delirium becomes fully manifest. In this proposal we plan on testing noninvasive, continuous monitors of mental status in the inpatient setting, primarily through the use of EEG.

Conditions

Delirium; Encephalopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients admitted to an inpatient hospital unit

Patients admitted to an inpatient hospital unit will receive EEG based monitoring of mental status

EEG

Intervention Type: DEVICE

EEG monitoring of brain rhythms

Interventions

EEG

EEG monitoring of brain rhythms

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Admitted to a general medical ward
• Expected stay of at least one night

Exclusion Criteria

• patients who have any scalp incisions or head wound(s) that would prevent EEG attachment
• Non-English speakers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eyal Y. Kimchi, M.D.,Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyal Y Kimchi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P000678

Identifier Type: -

Identifier Source: org_study_id