ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 46 of 279 for:    Cerebral Hypoxia

Measuring Brain Activity of School Age Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03407729
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Michael J. Decker, Case Western Reserve University

Brief Summary:
This observational study will investigate whether differences in birth events and oxygen levels during the newborn period affects the brain activity of children during the middle childhood years.

Condition or disease Intervention/treatment
Perinatal Hypoxia Dopamine Neurobehavioral Manifestations Other: Magnetic Resonance Imaging Other: Electroencephalography Other: Cognitive Performance Testing

Detailed Description:

The investigators will conduct an observational study comparing two groups of children to determine whether differences in birth events and oxygen levels during the newborn period lead to structural and functional impairment within the brain's dopaminergic pathways and the cortical regions innervated by those pathways. The dopaminergic system is involved in modulating motor control and cognitive function.

Using magnetic resonance diffusion tensor imaging (DTI), structural integrity of dopaminergic circuits will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term closely matched by age/sex/race.

Functional activity during executive function tasks will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term using functional magnetic resonance imaging-blood oxygen level dependent (fMRI-BOLD) with high density electroencephalography (HD-EEG). Assessment of motor function (grooved pegboard task) will also be performed.


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Structure & Function of Dopaminergic Brain Networks Following Postnatally-Occurring Hypoxic Insults
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Group/Cohort Intervention/treatment
Post-hypoxic former preterm
Born in the years 2005-2009 with birth gestational age between 23-28 weeks and birth weight appropriate for gestational age (AGA). Part of a research cohort with available oxygen saturation level data recorded continuously from the first day of life to 8 weeks postnatal age (n=20).Children will undergo Magnetic Resonance Imaging, Electroencephalography, and Cognitive Performance Testing.
Other: Magnetic Resonance Imaging
MRI uses a strong magnetic field and radio waves to create detailed images of the brain while the person's head is positioned inside a round tunnel.
Other Names:
  • DTI
  • fMRI-BOLD

Other: Electroencephalography
EEG tracks and records brain wave patterns. A head cap with small discs and thin wires (electrodes) is placed on the scalp, and then send signals to a computer.
Other Names:
  • EEG
  • High-density EEG (HD-EEG)

Other: Cognitive Performance Testing

For the Verbal n-back: During the fMRI scan, children will respond to a letter displayed on a small screen and indicate (by pushing a button) whether the letter shown is the same as a previously displayed letter.

For the Grooved Pegboard task: Prior to the MRI scan, children will be timed as they place pegs into holes with randomly positioned slots.

Other Names:
  • Verbal n-back
  • Grooved pegboard task

Healthy term-born children
Born in the years 2005-2009 with birth gestational age ≥ 38 weeks gestation and birth weight appropriate for term gestation (n=10) matched by age/sex/race to participating cohort children with no history of respiratory difficulty suggesting hypoxic exposure. Children will undergo Magnetic Resonance Imaging, Electroencephalography, and Cognitive Performance Testing.
Other: Magnetic Resonance Imaging
MRI uses a strong magnetic field and radio waves to create detailed images of the brain while the person's head is positioned inside a round tunnel.
Other Names:
  • DTI
  • fMRI-BOLD

Other: Electroencephalography
EEG tracks and records brain wave patterns. A head cap with small discs and thin wires (electrodes) is placed on the scalp, and then send signals to a computer.
Other Names:
  • EEG
  • High-density EEG (HD-EEG)

Other: Cognitive Performance Testing

For the Verbal n-back: During the fMRI scan, children will respond to a letter displayed on a small screen and indicate (by pushing a button) whether the letter shown is the same as a previously displayed letter.

For the Grooved Pegboard task: Prior to the MRI scan, children will be timed as they place pegs into holes with randomly positioned slots.

Other Names:
  • Verbal n-back
  • Grooved pegboard task




Primary Outcome Measures :
  1. Structural Integrity of Dopaminergic Circuits [ Time Frame: 30 minutes ]
    Assessment of dopaminergic circuits originating in the substantia nigra pars compacta (SNpc) and ventral tegmental area (VTA) that project to striatum, prefrontal cortex, and nucleus accumbens. Measured using Magnetic Resonance DTI.

  2. Functional activity during Executive Function Tasks [ Time Frame: 30 minutes ]
    Assessment of activity within cortical networks innervated by the substantia nigra pars compacta (SNpc) and ventral tegmental area (VTA). Measured using functional MRI-BOLD and MRI-compatible 64-electrode high-density electroencephalography (EEG).


Secondary Outcome Measures :
  1. Cognitive Performance [ Time Frame: 45 minutes ]
    Assessment of working memory and fine motor function. Measured using verbal n-back and grooved pegboard task


Biospecimen Retention:   Samples Without DNA
EEG recordings and MRI neuroimages


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study Group Children (n=20) will be drawn from a cohort currently maintained by the investigators.

Healthy Control Children will be recruited using various strategies: (1) study flyers given to the parents of the prematurely born cohort children to pass along to parents of other children with ages similar to their own child. (2) study flyers posted in the hospital's primary care pediatric clinics asking interested children/families to contact us to learn more about the study; (3) study flyers distributed by professional colleagues/pediatric physicians to potential candidate children/families meeting study inclusion criteria.

Criteria

Inclusion Criteria:

  1. For Study Group Children: Birth gestational age between 23-28 weeks and birth weight appropriate for gestational age (AGA) with available oxygen saturation level data recorded continuously from the first day of life to 8 weeks postnatal age (n=20)
  2. For Healthy Control Children: Birth gestational age ≥ 38 weeks gestation and birth weight appropriate for term gestation (n=10) matched by age/sex/race to participating cohort children.
  3. Born in years 2005-2009 (age range will be 8-15 years during the funding period)
  4. Ability of the child to provide assent, with the parent/legal guardian able to provide written informed consent for study procedures.
  5. Sensory and motor capability to complete study tasks (i.e. Grooved Pegboard test; verbal n-back word memory test). Mental Development index must be > 80 at 2-year-old follow-up for preterm cohort.

Exclusion Criteria:

  1. Current history of epilepsy to avoid confounding of EEG data
  2. Past history of concussion requiring medical treatment to avoid confounding of MRI data
  3. Current diagnosis of autism.
  4. Child who suffers from claustrophobia (per parent report).
  5. Unable to participate in neuroimaging due to claustrophobia, or medical contraindication to MRI including any implanted medical device, dental braces, surgical clips for aneurysms in the head, heart valve prostheses, electrodes or other metallic objects, pregnancy.
  6. Healthy control children who were treated in the Neonatal ICU in the newborn period for breathing difficulties.
  7. Healthy control children who were hospitalized for breathing problems in the first 3 months of infancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407729


Contacts
Contact: Elizabeth G Damato, PhD 216-368-2597 egd@case.edu
Contact: Michael J Decker, PhD 216-368-2912 mjd6@case.edu

Locations
United States, Ohio
Case Western Reserve University Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Elizabeth G Damato, PhD    800-825-2540 ext 2597    egd@case.edu   
Contact: Michael J Decker, PhD    800-825-2540 ext 2912    mjd6@case.edu   
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Michael J Decker, PhD Case Western Reserve University

Publications:

Responsible Party: Michael J. Decker, Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03407729     History of Changes
Other Study ID Numbers: 12266077
05-17-23 ( Other Identifier: UHCMC IRB )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Because this is a vulnerable population and a small sample size from a known cohort of children, it is unclear of the institutional requirements for sharing individual participant data in any format other than peer-reviewed publications. The investigators will make datasets from this study available upon completion of the study. Those who are interested will submit a brief research plan to the Principal Investigators. Qualified investigators whose research question can be appropriately addressed by the requested dataset will be invited to discuss their plan and finalize details with the investigators via phone or in person.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael J. Decker, Case Western Reserve University:
Hypoxia, Brain
Neural networks
Magnetic Resonance Imaging
EEG

Additional relevant MeSH terms:
Hypoxia
Neurobehavioral Manifestations
Signs and Symptoms, Respiratory
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases