Short-term And Longer-term Cognitive Impact Of Neurochecks

NCT06219889 | Recruiting

• 1 other identifier: UCSD IRB: #808348
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research plan seeks to understand the impact of sleep disruption in the Neurological Intensive Care Unit (ICU) on older patients with acute brain injury (ABI). In current practice, the neurocritical care community performs frequent serial neurological examinations ("neurochecks") in an effort to monitor patients for neurological deterioration following brain injury. Many neurocritical patients are older and/or cognitively fragile, and delirium is common. Although ICU delirium is multifaceted, frequent neurochecks may represent a modifiable risk factor if the investigators can better understand the risks and benefits of various neurocheck frequencies. This project will randomize patients with acute spontaneous intracerebral hemorrhage (ICH) to either hourly (Q1) or every-other-hour (Q2) neurochecks and evaluate the impact of neurocheck frequency on delirium. Second, longer-term cognitive outcomes will be investigated in patients with ICH randomized to Q1 versus Q2 neurochecks with the goal of identifying whether hourly neurochecks increase the risk for dementia.

Conditions

Intracerebral Hemorrhage

Keywords

neurochecks; serial neurological examination; delirium

Outcome Measures

Primary Outcomes (2)

• Delirium Duration (short - term cognitive)

  Cumulative duration (in multiple of 0.5 days) of incident delirium

  No more than 6 months after date of admission to ICU

• Long-term cognitive function

  NIH Toolbox: demographically corrected fluid cognition composite score

  6-month follow-up

Secondary Outcomes (3)

• Intensive care unit (ICU) length of stay

  No more than 6 months after date of admission to ICU

• Incident delirium

  No more than 6 months after date of admission to ICU

• Discharge destination

  No more than 6 months after date of admission to ICU

Other Outcomes (3)

• Depression

  6-month follow-up

• Anxiety

  6-month follow-up

• Post-traumatic Stress

  6-month follow-up

Study Arms (2)

Hourly Neurochecks

ACTIVE COMPARATOR

Patients will be awakened hourly for their examinations

Behavioral: Frequency of neurochecks

Every-Other-Hour Neurochecks

EXPERIMENTAL

Patients will be awakened every other hour for their examinations

Behavioral: Frequency of neurochecks

Interventions

Frequency of neurochecks BEHAVIORAL

the frequency with which a patient is awakened to perform serial examinations

Every-Other-Hour Neurochecks; Hourly Neurochecks

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age \>18 years) with spontaneous acute \<45cc in volume with radiographic and clinical stability for ≥6 hours following admission to the ICU. These criteria are based on the literature and experience of the investigative team.
• Additional intraventricular hemorrhage (with or without external ventricular drain) is allowable.
• Only first admission to the NeuroICU during the hospitalization will be eligible.
• a. any patient included in part 1 alive at 6 months post-discharge

You may not qualify if:

• Patients with unstable intracranial bleeding
• Patients with known history of intracranial neurological injury
• Pre-existing cognitive impairment (known or highly suspected based on family-provided history, Activities of Daily Living Questionnaire)
• Pre-existing diagnosed sleep disorder
• Comatose or heavily sedated
• Death expected within 30 days or other terminal illness
• ICH score \>4 (equivalent to mortality risk \>72%)
• Pregnancy
• Incarcerated
• Non-English or non-Spanish speaking

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Health

San Diego, California, 92103, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Delirium

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jamie N LaBuzetta

CONTACT

18582491331; jlabuzetta@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Neurosciences

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 23, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: No sooner than at the time of study closure
• Access Criteria: The full de-identified dataset will be made available for sharing utilizing a repository. All data sharing practices are scrutinized for HIPAA compliance and other best practices around data use agreements (DUAs). Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes.

Locations

US (1)