Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebral Palsy and the Study of Brain Activity During Motor Tasks

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: NCT01829724
Recruitment Status : Recruiting
First Posted : April 11, 2013
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease
Cerebral Palsy Children

Detailed Description:

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 biofeedback 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Near-infrared Spectroscopy and Electroencephalography to Assess and Train Cortical Activation During Motor Tasks
Actual Study Start Date : August 22, 2013
Estimated Primary Completion Date : October 15, 2026

Resource links provided by the National Library of Medicine


Group/Cohort
Healthy volunteer
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.
Individuals with childhood-onset brain or peripheral injury
The childhood-onset brain injury group 120 individuals spanning the three objectives.



Primary Outcome Measures :
  1. changes in brain activation and motor performance in childhood-onset brain injury before and after a short training program. [ Time Frame: real time ]
    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.



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.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria
  • INCLUSION CRITERIA
  • Age 5 years of older
  • Surgery free for six months in either the upper or lower extremities.
  • Free from botulinum toxin injections within four months in either the upper or lower extremities.
  • 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


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): NCT01829724


Contacts
Layout table for location contacts
Contact: Functional & Applied Biomechanics Sectio (301) 412-5989 ccrmdfab@mail.nih.gov
Contact: Diane L Damiano, Ph.D. (301) 451-7544 damianod@cc.nih.gov

Locations
Layout table for location information
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 TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Layout table for investigator information
Principal Investigator: Diane L Damiano, Ph.D. National Institutes of Health Clinical Center (CC)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01829724    
Other Study ID Numbers: 130110
13-CC-0110
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 19, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .Protocol is silent in IPD sharing.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC):
Functional Brain Imaging
Cerebral Palsy
Motion Analysis
Macro-EMG
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases