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Near-infrared Spectroscopy and EEG for Cortical Activation in Children with Brain Injuries

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Study Aim

This study aims to observe changes in brain activation and motor performance in children with brain injuries before and after a short training program using near-infrared spectroscopy and EEG.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Brain Damage, Chronic+2

+ Brain Diseases

+ Central Nervous System Diseases

From 5 to 100 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2013
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Study ContactFunctional & Applied Biomechanics SectioMore contacts
Last updated: August 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 22, 2013

Actual date on which the first participant was enrolled.

Objective Neural imaging during functional tasks has become more portable and accessible than magnetic resonance imaging (MRI) by utilizing non-invasive near-infrared spectroscopy (NIRS) as a means to isolate areas of brain activity by measuring blood flow dynamics and electroencephalography (EEG) to measure electrical activity on the cortical surface. Although use of these technologies for assessing cortical activation patterns is increasing, validation of these approaches, particularly in children with brain injuries such as cerebral palsy is in the early stages with few reports in the literature. The use of these in motor training paradigms for rehabilitation populations has not yet been reported. The objectives of this protocol are to: 1) systematically compare cortical activation patterns associated with specified motor and sensory tasks in healthy children and adults to those with unilateral or bilateral childhood-onset brain injury 2) extend the use of EEG in our laboratory across subject groups and tasks, when used alone or with NIRS; and 3) pilot the use of NIRS and/ or EEG as a brain neurofeedback device in children with childhood-onset brain or peripheral injuries. The first two objectives are observational only, the third objective includes a pilot intervention. The results of this study are expected to increase knowledge of brain activation patterns across tasks and groups with and without brain injuries and to provide proof of concept and power estimates for future clinical studies with these technologies. A secondary question we would like to examine with these imaging technologies is the potential effect of motor impairments resulting from childhood-onset peripheral injuries (e.g. obstetrical brachial plexus palsy) on brain reorganization. Study population The childhood-onset brain injury group will consist of up to120 individuals (5 years and above) spanning the three objectives. The childhood-onset peripheral injury group will consist of up to 100 individuals within the same age-range spanning only Objectives 1 and 2. The control groups for each participant cohort will consist of up to 50 individuals spanning Objectives 1 and 2, for a total recruitment of up to 100 healthy volunteers within the same age range. Design Objective 1, the primary focus of this research protocol, is a cross-sectional analysis of multiple tasks across subject groups with and without motor impairments. Objective 2 is primarily a descriptive study, and Objective 3 is a pilot evaluation of the effectiveness of novel short term motor training program in children with childhood-onset brain injury targeted at improving brain activation patterns and motor performance. Outcome measures Objective 1 is the primary quantitative objective in this protocol, in which we will compare location, magnitude, volume and area of cortical activation across tasks and groups. Secondary outcomes include descriptive measures that will be used primarily to evaluate the two techniques or to monitor motion and muscle activation (EMG and ultrasound) data to help interpret task and group differences. Objective 3 will measure changes in brain activation and motor performance in childhood-onset brain injury before and after a short training program.

NCT01829724
Principal SponsorNational Institutes of Health Clinical Center (CC)
Study ContactFunctional & Applied Biomechanics SectioMore contacts
Last updated: August 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

320 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Palsy

Criteria

8 inclusion criteria required to participate
Able to provide informed consent (Guardian or parent of child participants) or verbal/written assent as appropriate (for child participant)

Able to understand and follow simple directions that include how to perform a repetitive task and when to start and stop doing the task, based on parent report if the subject is a child and physician observation during history and physical examination

Able to walk at least 20 feet without stopping with or without a walking aid

Age 5 years and older

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12 exclusion criteria prevent from participating
Additional exclusion criteria for EEG

Additional exclusion criteria for MRI

Adult who can t consent for themselves

Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than childhood-onset brain or peripheral injury that would affect the ability to mentally concentrate or move a body part repetitively for short periods of time. Examples of this include, but are not limited to, congestive heart failure, end stage cardiac disease, or fractures that have not completely healed

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
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One Study Center