Skip to main content
OpenTrials
Completed

NCT Number: NCT01786785

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy Control Subjects

  • Subjects age 2-18 years inclusive
  • No history of congenital or acquired brain injury
  • No history of developmental delay, mental retardation, genetic or metabolic syndrome affecting the brain

Inclusion criteria

AIS Subjects

  • Subjects age 2-18 years inclusive
  • 72 hours or less from stroke onset
  • MRI or CT confirmation of AIS

Exclusion criteria

for All Subjects

  • Skull defect preventing application of probes
  • Moyamoya disease
  • Sickle cell anemia

Treatment and study plan

Primary outcomes

  1. Reduction in microvascular blood flow in supine position

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

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

Registry information

Official study title

Optical Measurement of Cerebral Hemodynamics in Children With Acute Arterial Ischemic Stroke: A Pilot Study

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2013
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.