RECRUITING

Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain injury (TBI), ischemic stroke (IS), and intraparenchymal hemorrhage (IPH), which can manifest rapidly within hours or more gradually over days. Despite advancements in surgical management, significant gaps in understanding persist regarding optimal monitoring and therapeutic approaches. The current standard for identifying LTME involves neurologic decline in conjunction with radiographic evidence or increased intracranial pressure (ICP) indicating space-occupying mass effect. However, in critically ill patients, reliance on subjective physical exam findings, such as decreased arousal, often leads to delayed recognition, occurring only after catastrophic shifts have already occurred. The goal of this study is to determine the association of non-invasive biomarkers with neurologic deterioration, and to determine whether non-invasive biomarker inclusion improves detection of outcome and decline. The investigators propose to use various non-invasive methods to monitor ICP as adjuncts in detecting deteriorating mass effect. These methods include quantitative pupillometry, radiographic data, laboratory data, and other bedside diagnostic tests available including electroencephalography (EEG), skull vibrations detected via brain4care device, optic nerve sheath diameter assessment (ONSD), and ultrasound-guided eyeball compression. Some of these methods will be measured \*only\* for the purposes of the research study (such as skull vibrations via brain4care). Other measurements, such as quantitative pupillometry, will represent additional measurements beyond those already being collected for clinical care. This research study is necessary to understand the association of these non-invasive biomarkers with neurological decline and outcomes while considering potential confounding factors.

Official Title

Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

Quick Facts

Study Start:2024-09-26
Study Completion:2030-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06504238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Admitted under Neuro intensivist primary or consultative care.
  2. * At least one head computed tomography (CT) scan demonstrating intracranial pathology that may lead to life-threatening mass effect (i.e. traumatic brain injury, ischemic or hemorrhagic stroke, epidural or subdural hematoma, subarachnoid hemorrhage, diffuse hypoxic injury, metabolic cerebral edema, tumor)
  3. * Concern for Life Threatening Mass Effect
  4. * Glasgow Coma Score (GCS) \<9
  5. * Anticipated stay \>24 hours
  1. * Comfort measure only
  2. * Any other criteria that the PI deems that makes the patient inadequate for the study
  3. * Sub-exclusion criteria for specific non-invasive measurements include:
  4. * Orbital injury (pupillometry, ONSD)
  5. * Traumatic injury or surgery that precludes use of B4C device
  6. * Presence of supratentorial craniectomy or craniotomy that has not healed and is mobile/bone defects/scalp injury \[EEGelectroencephalogram (EEG), Brain4Care\]
  7. * Presence of extensive scalp injury

Contacts and Locations

Study Contact

Charlene Ong, MD MPHS
CONTACT
617 638 5351
cjong@bu.ed
Leigh Mallinger, BA
CONTACT
617-638-7732
leigh.mallinger@bmc.org

Principal Investigator

Charlene Ong, MD MPHS
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Neurology

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Charlene Ong, MD MPHS, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Neurology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-26
Study Completion Date2030-09

Study Record Updates

Study Start Date2024-09-26
Study Completion Date2030-09

Terms related to this study

Keywords Provided by Researchers

  • Life-threatening mass effect (LIME)
  • Traumatic brain injury (TBI)
  • Ischemic stroke (IS)
  • Intraparenchymal hemorrhage (IPH)
  • Neurologic deterioration
  • Intracranial Pressure (ICP)
  • Glasgow Coma Scores

Additional Relevant MeSH Terms

  • Brain Injury, Acute