Recruiting

Neurochecks

Sponsor:

UCLA

Code:

NCT06219889

Conditions

Intracerebral Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Frequency of neurochecks

Study Details

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

Study ID

NCT06219889

Start date

Jul 8, 2024

Status verified date

Sep, 2025

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria (Part 1):

1. 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.
2. Additional intraventricular hemorrhage (with or without external ventricular drain) is allowable.
3. Only first admission to the NeuroICU during the hospitalization will be eligible.

Inclusion criteria (Part 2):

a. any patient included in part 1 alive at 6 months post-discharge

Exclusion Criteria:

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Hourly Neurochecks

Patients will be awakened hourly for their examinations

experimental: Every-Other-Hour Neurochecks

Patients will be awakened every other hour for their examinations

Interventions

Frequency of neurochecks

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

Primary outcome measure

  • Delirium Duration (short - term cognitive) [ Time Frame: No more than 6 months after date of admission to ICU ]
  • Long-term cognitive function [ Time Frame: 6-month follow-up ]

Central Contacts and Locations

Central contacts

Jamie N LaBuzetta

18582491331jlabuzetta@ucsd.edu

Locations

UC San Diego Health

Recruiting

San Diego, California, United States, 92103

Contacts

Jamie N LaBuzetta

619-543-6222jlabuzetta@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • neurochecks
  • serial neurological examination
  • delirium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-09-10.