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Protocol Details

Near-infrared Spectroscopy and Electroencephalography to Assess and Train Cortical Activation During Motor Tasks

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-CC-0110

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 mo
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Functional Brain Imaging;
Cerebral Palsy;
Motion Analysis;
Macro- EMG

Recruitment Keyword(s)

None

Condition(s)

Brain Function

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

Background:

- Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better.

Objectives:

- To study how the brain controls body movement in people with and without cerebral palsy.

Eligibility:

- Individuals at least 5 years of age who have cerebral palsy.

- Healthy volunteers at least 5 years of age.

Design:

- This study has three parts. People with cerebral palsy will be selected for all three. Healthy volunteers will be asked to do only two of them. Everyone who participates will have NIRS and/or EEG exams during movement. People with cerebral palsy may also have biofeedback sessions to train coordination of movement and brain activity.

- Participants will be screened with a physical exam and medical history. Urine samples may be collected.

- All participants will have at least one session of NIRS and/or EEG imaging studies. Sessions may also include the following tests:

- Magnetic resonance imaging to look at the brain

- Electromyography to measure electrical activity of the muscles

- Motion analysis of specific body parts

- Ultrasound to measure activity of the muscles

- Motorized, robotic, and electrical stimulation of the muscles

- Other clinical tests of muscle movement as needed.

- Participants with cerebral palsy will have biofeedback sessions. These sessions will help them learn to coordinate muscle movement and brain activity.

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Eligibility

INCLUSION CRITERIA

-Age 5 years of older

-Either a healthy volunteer or have a diagnosis of a childhood-onset (before 13 years of age) brain injury resulting in motor impairment of one arm and one leg on the same side of the body or motor impairment of both legs or have a diagnosis of childhood-onset (before 13 years of age) peripheral injury resulting in sensory or motor impairment of any limb or multiple limbs.

-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

-Able to provide informed consent (for adult participants or parent of child participants) or verbal/written assent (for child participant).

-Agreement to not drink caffeine or alcohol for 24 hours before each assessment session because both agents can modify brain activity and may confound outcome measures.

EXCLUSION CRITERIA:

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, myopathies, demyelinating conditions, congestive heart failure, end stage cardiac disease, or fractures that have not completely healed.

Uncontrolled seizures.

Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl, dantrolene sodium, tizanidine, or carbidopa/levodopa). If patients are taking these medications daily, the treating physician will be contacted by the MAI to determine if it is acceptable for the subject to temporarily discontinue the medication(s) for 24 hours prior to participating in testing for this study for each of the first 2 objectives. If that is not deemed to be safe, the subject will be excluded. Subjects who are on these medications will not be allowed to participate in Objective 3.

To participate in Objective 1, it is preferable that all subjects be willing and able to have, or have previously had, a structural MRI to aid in the interpretation of results. Inability or refusal to complete an MRI, or to provide access to a previous structural MRI scan, will not constitute an exclusion criterion for this study.

Additional exclusion criteria for MRI

-Inability to lie flat on the back for up to 45 minutes without sedation.

-Discomfort being in small spaces for up to 45 minutes.

-Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth that cannot be safely removed.

-Pregnancy: For any female of childbearing potential, a pregnancy test will be done. Childbearing potential will be determined during the history and physical.

Additional exclusion criteria for EEG

-History of allergic reaction to water-based electrode gel


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Citations:

Rigoldi C, Molteni E, Rozbaczylo C, Morante M, Albertini G, Bianchi AM, Galli M. Movement analysis and EEG recordings in children with hemiplegic cerebral palsy. Exp Brain Res. 2012 Dec;223(4):517-24. doi: 10.1007/s00221-012-3278-2.

Gwin JT, Gramann K, Makeig S, Ferris DP. Electrocortical activity is coupled to gait cycle phase during treadmill walking. Neuroimage. 2011 Jan 15;54(2):1289-96. doi: 10.1016/j.neuroimage.2010.08.066.

Presacco A, Goodman R, Forrester L, Contreras-Vidal JL. Neural decoding of treadmill walking from noninvasive electroencephalographic signals. J Neurophysiol. 2011 Oct;106(4):1875-87. doi: 10.1152/jn.00104.2011.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Diane L. Damiano, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7544
damianod@cc.nih.gov

Sara F. Sadeghi
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7529
sara.sadeghi@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01829724

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