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

NCT ID: NCT01786785

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-10-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Arterial Ischemic Stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke Patients

Subjects between 2 and 17 years of age with a confirmed arterial ischemic stroke.

No interventions assigned to this group

Controls

Age and Gender Matched Controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

1. Skull defect preventing application of probes
2. Moyamoya disease
3. Sickle cell anemia
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Alavi-Dabiri Postdoctoral Fellowship Award

UNKNOWN

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel L Licht, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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K12NS049453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-008442

Identifier Type: -

Identifier Source: org_study_id

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