Optical Measurement of Cerebral Hemodynamics in Children With Acute Arterial Ischemic Stroke

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Completed
CT.gov ID
NCT01786785
Collaborator
Thrasher Research Fund (Other), National Institutes of Health (NIH) (NIH), Alavi-Dabiri Postdoctoral Fellowship Award (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
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Study Details

Study Description

Brief Summary

Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top ten causes of death in children. Currently, caregivers lay the affected child flat in hopes of increasing blood flow to the brain and reducing the volume of the brain which is damaged. However, there are currently no techniques to measure brain blood flow at the child's bedside and indicate if this treatment is effective. We will probe brain blood volume, oxygen saturation, and flow with red light to determine the efficacy of this intervention.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Arterial ischemic stroke (AIS) affects about 2 children per 100,000 per year and is one of the top 10 causes of mortality in children. After stroke, there is a disturbance in cerebral blood flow (CBF) autoregulation, and changes in head position may change CBF. Currently, practice at the Children's Hospital of Philadelphia (CHOP) is to keep the head of bed (HOB) of a child with AIS flat for 24 hours; however, there is no evidence that this practice is efficacious in children. Furthermore, maintaining a child supine for 24 hours is uncomfortable for the child and is often unenforceable in younger children. This study will use a noninvasive optical technique to measure CBF as HOB position is changed to assess the effectiveness of head of bed position in increasing CBF in children with acute arterial ischemic stroke.

    The primary objectives are to determine the difference in CBF at HOB flat (0 degrees) and HOB at +30 degrees in healthy children and in children with AIS. The secondary objectives are to examine CBF in healthy children and in children with AIS at other HOB angles (0, +15, and +30 degrees) compared to the CBF at HOB 0 degrees and to determine if the position that maximizes CBF varies over time from stroke onset.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    15 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Optical Measurement of Cerebral Hemodynamics in Children With Acute Arterial Ischemic Stroke: A Pilot Study
    Study Start Date :
    Feb 1, 2012
    Actual Primary Completion Date :
    Oct 22, 2016
    Actual Study Completion Date :
    Oct 22, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Stroke Patients

    Subjects between 2 and 17 years of age with a confirmed arterial ischemic stroke.

    Controls

    Age and Gender Matched Controls

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in microvascular blood flow in supine position [72 hours post stroke]

      Microvascular blood flow will be measured at 24, 48, and 72 hours post stroke, with the head of bed at 30, 15, and 0 deg (supine). Current clinical practice is to lower the head of bed to the supine position to increase blood flow.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria Healthy Control Subjects

    1. Subjects age 2-18 years inclusive

    2. No history of congenital or acquired brain injury

    3. No history of developmental delay, mental retardation, genetic or metabolic syndrome affecting the brain

    Inclusion Criteria AIS Subjects

    1. Subjects age 2-18 years inclusive

    2. 72 hours or less from stroke onset

    3. MRI or CT confirmation of AIS

    Exclusion Criteria for All Subjects

    1. Skull defect preventing application of probes

    2. Moyamoya disease

    3. Sickle cell anemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Children's Hospital of Philadelphia
    • Thrasher Research Fund
    • National Institutes of Health (NIH)
    • Alavi-Dabiri Postdoctoral Fellowship Award
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Daniel L Licht, MD, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital of Philadelphia
    ClinicalTrials.gov Identifier:
    NCT01786785
    Other Study ID Numbers:
    • 11-008442
    • K12NS049453
    First Posted:
    Feb 8, 2013
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2022