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

Acute Arterial Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786785
• Other study ID #: 11-008442
• Secondary ID: K12NS049453
• Status: Completed
• Start date: February 2012
• Est. completion date: October 22, 2016

Study information

• Verified date: April 2022
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 22, 2016
• Est. primary completion date: October 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Arterial Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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