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Intracerebral HemorrhageNCT06219889

Short-term And Longer-term Cognitive Impact Of Neurochecks

A study testing Frequency of neurochecks in people with Intracerebral Hemorrhage, run by University of California, San Diego at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Frequency of neurochecks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
8 Jul 2024to 31 Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • ICH score >4 (equivalent to mortality risk >72%)
  • Pregnancy
  • Incarcerated
  • Non-English or non-Spanish speaking

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jamie N LaBuzetta contact

18582491331

jlabuzetta@ucsd.edu

United States1 site, 1 recruiting
  • UC San Diego Health

    San Diego, California, 92103

    Jamie N LaBuzetta, 619-543-6222, jlabuzetta@ucsd.edu

    Recruiting

Other trials in United States

About this study

Official title: Short-term And Longer-term Cognitive Impact Of Hourly Neurochecks In Acute Brain Injury

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.

Read the detailed description

Usual care: Patients with ICH are cared for in the NeuroICU by a specialized team including Board-certified neurointensivists, nurse practitioners, and neuro-trained bedside nurses (neuroRNs). These neuroRNs each undergo intensive specialized training on the neurological exam, diagnosis, and acute management of neuro-complications, and maintain their knowledge via regular audits and through annual continuing education. The CAM-ICU tool is the most well-known and robustly utilized tool to assess ICU delirium, and has been validated in the poststroke population. The investigators have tight adherence to detailed protocols for multidisciplinary management of potential confounders including coagulopathy, cerebral edema, blood pressure (goal 130-150mmHg systolic), nutrition, glucose control, and early mobility. Pain management utilizes Tylenol and short-acting opiates in non-intubated patients. In intubated patients, our goal RASS (Richmond Agitation Sedation Score) is 0 to -2 and the investigators prioritize analgosedation with fentanyl, propofol and/or dexmedetomidine.

This intervention: Patients will be randomized (random number generator) to Q1 or Q2 neurochecks, which will be performed by the bedside expert neuroRNs. Once randomized, the investigators will monitor patients during their ICU admission with data prospectively collected to include: patient and clinical demographic information (e.g., age, severity and location of ICH), pre-admission sleep quality (via Pittsburgh Sleep Quality Index), medical complications during ICU admission, incident delirium per ICU stay (as measured by CAM-ICU screening tool performed by the bedside nurses each shift; yes/no) as well as time elapsed in the hospital prior to developing delirium, frequency of neurochecks at time of incident delirium, ICU and hospital lengths of stay (LOS), consecutive and total duration of delirium (as measured by CAM-ICU), discharge destination (including death), techniques used to manage delirium (e.g., antipsychotic medication administration with total dosages), and pharmacotherapy for pain (e.g., opiate frequency and dosing). Safety data (i.e., mortality, upgrade in frequency of neurochecks, adverse events) will be collected throughout the study (see details in DSMP). Given a reported association between ApoE allele and early onset delirium and delirium duration, all enrolled patients will undergo saliva sampling (4 buccals swabs) for ApoE allele status.

Long-term outcomes:

Patients enrolled in will be followed longitudinally for longer-term neuropsychological assessment at 6-months post-discharge. Assessment will be performed using the comprehensive cognitive and emotional batteries through NIH Toolbox® along with supplemental cognitive measures (e.g., Auditory Verbal Learning, AVLT) and additional mood/emotional screening questionnaires (e.g., HAM-A, IES-R). The NIH Toolbox® is chosen because of its validation in neurological patients with stroke and relative resilience against learning effects. By giving a wide range of verbal and nonverbal tests and using typical methods of cognitive assessment (e.g., delayed AVLT), the investigators can address our outcomes independent of verbal dysfunction from dominant hemisphere lesions and over time as a function of domain-specific impairments. This aim will also capture retention statistics and participant impressions/willingness to participate after 6 months.

Being tested
Frequency of neurochecks
Keywords
neurochecks, serial neurological examination, delirium
Medical subject headings
Cerebral Hemorrhage, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Frequency of neurochecksBehavioural

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

Study groups in NCT06219889
Study groupRoleWhat they receive
Hourly NeurochecksActive comparatorPatients will be awakened hourly for their examinations
Receives: Behavioral: Frequency of neurochecks
Every-Other-Hour NeurochecksExperimentalPatients will be awakened every other hour for their examinations
Receives: Behavioral: Frequency of neurochecks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delirium Duration (short - term cognitive)

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

    Measured: No more than 6 months after date of admission to ICU

  2. Long-term cognitive function

    NIH Toolbox: demographically corrected fluid cognition composite score

    Measured: 6-month follow-up

Secondary outcomes (3)
  1. Intensive care unit (ICU) length of stay

    Length of time spent in the ICU from time of ICU admission through time of ICU discharge

    Measured: No more than 6 months after date of admission to ICU

  2. Incident delirium

    Delirium that developed once the participant was admitted to the hospital

    Measured: No more than 6 months after date of admission to ICU

  3. Discharge destination

    The location to which the patient is discharged, including death

    Measured: No more than 6 months after date of admission to ICU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start8 Jul 2024
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219889
Sponsor's protocol ID
UCSD IRB: #808348
Status last verified
Sep 2025
First submitted
6 Dec 2023
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Per NIH guidelines, will provide anonymized data to qualified investigator

Questions about this trial

What is this clinical trial studying?

A study testing Frequency of neurochecks in people with Intracerebral Hemorrhage, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jamie N LaBuzetta (18582491331, jlabuzetta@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delirium Duration (short - term cognitive) (time frame: No more than 6 months after date of admission to ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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