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

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status

Completed

Conditions

Acute Arterial Ischemic Stroke

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01786785
11-008442
K12NS049453 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

2 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

15 participants in 2 patient groups

Stroke Patients
Description:
Subjects between 2 and 17 years of age with a confirmed arterial ischemic stroke.
Controls
Description:
Age and Gender Matched Controls

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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