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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Arterial Ischemic Stroke

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Stroke Patients; Subjects between 2 and 17 years of age with a confirmed arterial ischemic stroke.
Controls; Age and Gender Matched Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in microvascular blood flow in supine position	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.	72 hours post stroke

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH); Thrasher Research Fund; Alavi-Dabiri Postdoctoral Fellowship Award
• Investigators: Principal Investigator: Daniel L Licht, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 22, 2016
• Study Completion (Actual): October 22, 2016

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 11-008442; K12NS049453 (U.S. NIH Grant/Contract)