Study to Assess and Monitor Brain Activity

NCT04602988 | Unknown

• 1 other identifier: 2020P000678
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Keywords

EEG; Mental Status

Outcome Measures

Primary Outcomes (2)

• Delirium Severity

  Inpatient Delirium as assessed by the 3D-CAM-S

  Daily during the time of EEG recording up to 7 days

• EEG

  Relative EEG power in the delta \& theta bands

  Daily during the time of EEG recording up to 7 days

Secondary Outcomes (1)

• Functional status

  3 months after completion of EEG recording

Study Arms (1)

Patients admitted to an inpatient hospital unit

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

Device: EEG

Interventions

EEG DEVICE

EEG monitoring of brain rhythms

Patients admitted to an inpatient hospital unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited after their admission to inpatient medical units at the participating hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Delirium; Brain Diseases

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Eyal Y Kimchi, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 26, 2020
• Study Start: August 10, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

US (1)