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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Children's Hospital of Philadelphia
Sponsor:
Collaborators:
Thrasher Research Fund
Alavi-Dabiri Postdoctoral Fellowship Award
Information provided by (Responsible Party):
Daniel Licht, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01786785
First received: February 6, 2013
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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
Acute Arterial Ischemic Stroke

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Optical Measurement of Cerebral Hemodynamics in Children With Acute Arterial Ischemic Stroke: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Reduction in microvascular blood flow in supine position [ Time Frame: 72 hours post stroke ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 74
Study Start Date: February 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke Patients
Subjects between 2 and 17 years of age with a confirmed arterial ischemic stroke.
Controls
Age and Gender Matched Controls

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 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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children (2-18 y.o.) presenting at the Children's Hospital of Philadelphia with a confirmed arterial ischemic stroke

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786785

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Daniel J Licht, MD    267-426-0122    licht@email.chop.edu   
Sub-Investigator: David R Busch, PhD         
Sponsors and Collaborators
Daniel Licht
Thrasher Research Fund
Alavi-Dabiri Postdoctoral Fellowship Award
  More Information

No publications provided

Responsible Party: Daniel Licht, Attending Physician, Professor, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01786785     History of Changes
Other Study ID Numbers: 11-008442
Study First Received: February 6, 2013
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014