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Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03434080
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

New ways to study the brain as people move include near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses laser light shone through the scalp to look at blood flow in the brain which increases with movement. EEG records electrical activity in the brain. Little is known about brain activity while children learn new motor skills. Researchers want to learn more about how small children with and without cerebral palsy use their brain to control their body. This may help them find new ways to help children move better.

Objectives:

To learn more about how infants and young children with and without cerebral palsy use their brain to move their arms and legs.

Eligibility:

Children ages 3 months - 5 years with and without cerebral palsy

Design:

Participants will be screened with:

  • Physical exam
  • Questions for the parents about the child s health

Participants will have at least 1 study session. Some may have up to 34 (all optional).

In the sessions, participants will do motor tasks along with some or all of the following:

  • Light sensors placed on the scalp, held there with a cap or Velcro straps.
  • Small metal disks placed on the scalp with a cap or straps, with gel between them.
  • Motion capture recording. Balls attached to the arms and legs by stickers, straps, or a garment are tracked by infrared and video cameras.

Motor tasks include reaching, clapping, kicking, and standing.

Participants may be placed in a toy or device that uses a motor to move their limbs.

Participants head size, hair, and skin will be assessed.

Parents will answer questions about their child s typical movements.


Condition or disease
Cerebral Palsy

Detailed Description:

OBJECTIVE

Portable neural imaging during functional tasks is now possible utilizing noninvasive near-infrared spectroscopy (NIRS) which identifies areas of brain activity by measuring blood flow dynamics and electroencephalography (EEG) which measures electrical activity on the cortical surface. Use of these technologies for studying movement is rapidly increasing; however, investigations in children and those with brain injuries such as cerebral palsy are still in the early stages with few reports in the literature. The objectives of this protocol are to systematically compare cortical activation patterns during specified sensorimotor tasks in healthy infants and young children to those with cerebral palsy, examine developmental changes in brain activation patterns that underlie the emergence of early functional or dysfunctional motor control and explore the neural and biomechanical effects of different devices that make movement easier for infants and toddlers with cerebral palsy. The results are expected to increase knowledge of brain activation patterns across tasks and groups with and without brain injuries and to suggest potential mechanisms or strategies for future clinical intervention trials.

STUDY POPULATION

The group with cerebral palsy will consist of up to 100 children ages 3 months up to 5 years of age. The control group will consist of 50 healthy volunteers within the same age range.

DESIGN

This is an observational study that will include cross-sectional and longitudinal data collection. NIRS and/or EEG responses, and kinematic and/or electromyography (EMG) recordings will be collected on all participants during the performance of self-initiated motor tasks. Additionally, we will evaluate brain and motor responses to devices that aim to make movement easier for infants and children with motor disabilities who may have difficulty initiating or performing these movements without assistance.

OUTCOME MEASURES

Primary outcomes are the magnitude, extent and location of brain activity recorded by NIRS and/or EEG within tasks across subject groups. We will also quantify changes in brain activation across ages (cross-sectional) and time (longitudinal).

Secondary outcomes include motion and EMG data to help interpret task and group differences and measures of motor abilities. The same outcome measures will be compared across ages to examine the development of cortical activation patterns and motor abilities and how these change over time and across groups.


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : August 17, 2019
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
Children with cerebral palsy, ages 3 months up to 5 years of age.
Healthy Volunteers
Children without cerebral palsy, ages 3 months up to 5 years of age.



Primary Outcome Measures :
  1. Magnitude, extent and location of brain activity recorded by NIRS and/or EEG within tasks across subject groups. We will also quantify changes in brain activation across ages (cross-sectional) and time (longitudinal). [ Time Frame: One or more days ]

Secondary Outcome Measures :
  1. Include motion and EMG data to help interpret task and group differences and measures of motor abilities. The same outcome measures will be compared across ages to examine the development of cortical activation patterns and motor abilities and h... [ Time Frame: one or more days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children ages 3 months - 5 years with and without cerebral palsy. The group with cerebral palsy will consist of up to 100 children. The control group will consist of 50 healthy volunteer children.
Criteria
  • INCLUSION CRITERIA:
  • Age 3 months up to 5 years of age
  • Either a healthy volunteer or have a diagnosis of CP.

EXCLUSION CRITERIA:

  • Has any injury or health condition other than CP that affects the ability to move a body part repetitively for short periods. Examples include spinal cord injury, muscle diseases, congestive heart failure, or recently broken bones. The physician will discuss the child s health history during the screening to determine if participation is safe.
  • (for EEG) A history of allergic reaction to water-based electrode gel.

Additional exclusion criteria for infants and young children with CP

  • Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl, dantrolene sodium, tizanidine, or carbidopa/levodopa).
  • Surgery within the past year or botulinum toxin injections within the past four months.
  • A history of having had a major seizure or now diagnosed as having a seizure disorder and is on medication for seizures (e.g. may have had a mild seizure(s) in the past but is not currently being treated for seizures).
  • Chronic respiratory problems that require the use of oxygen.
  • Children of investigators and children of subordinates to an investigator.

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): NCT03434080


Contacts
Contact: Sara F Sadeghi (301) 451-7529 sara.sadeghi@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Diane L Damiano, Ph.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT03434080     History of Changes
Other Study ID Numbers: 180052
18-CC-0052
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: February 6, 2018

Keywords provided by National Institutes of Health Clinical Center (CC):
Pediatric
Neuroimaging
Brain Function
Voluntary Movement

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases