Study to Assess and Monitor Brain Activity

Active, not recruiting

• Conditions: Delirium; Encephalopathy
• Interventions: Device: EEG

• Registration Number: NCT04602988
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-10
• Study First Submitted: 2020-10-18
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-08
• Primary Completion: 2024-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
EEG	Daily during the time of EEG recording up to 7 days	Relative EEG power in the delta \& theta bands
Delirium Severity	Daily during the time of EEG recording up to 7 days	Inpatient Delirium as assessed by the 3D-CAM-S

Secondary Outcome Measures

Name	Time	Method
Functional status	3 months after completion of EEG recording	Functional status as assessed by the Glasgow Outcome Score (1-5, with lower numbers less favorable outcomes and higher numbers more favorable outcomes)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States