Cerebral PalsyNCT00100503
Brain Reorganization Following Constraint-Induced Therapy in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how therapy changes the way the brain controls movements in children with cerebral palsy. Normally, one side of the brain controls movements in the opposite side of the body. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2004to 30 Aug 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 9 to 17 years of age.
- Cerebral palsy patients:
- Children previously diagnosed with spastic hemiplegia subtype of cerebral palsy
- Children with non-progressive cerebral lesions acquired pre-, peri- or post-natally, before 1 year of age.
- Typically Developing subjects:
- Scores below 60 on Connor's attention deficit/hyperactivity disorder (ADHD) checklist.
- Normal neurological history and examination
Who cannot join
- Any child who is pregnant
- Patients with Development Quotient (DQ) or Intelligence Quotient (IQ) below 50 on standardized tests
- Cerebral palsy patients:
- Children with subtypes of cerebral palsy that are not hemiplegia.
- Children with uncontrolled seizures within the last 6 months
- Children with progressive or neurodegenerative disorders; underlying known genetic or chromosomal disorders, familial or non-familial syndromes (without known chromosomal or genetic defect)
Show all 17Show fewer
- Patients with cerebral lesions caused by sickle cell disease or by emboli associated with congenital cardiac lesions
- Patients incapable of voluntary movement or with severe cognitive deficits who cannot follow simple verbal commands
- Typically Developing Children:
- Children with chronic medical disorders or any neurological and /or psychiatric disorder including attention deficit hyperactivity disorder or learning disorder
- Children taking regular medications, including medications for allergies, hormonal oral contraceptives, or over-the-counter medications
- Children born before 36 weeks gestation as estimated by dates, ultrasound or other methods (if a discrepancy exists, then the ultrasound estimation will be taken as definitive)
- Exclusionary criteria for clinical MRI studies:
- Any child with metal objects in the body such as pacemakers, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses, cochlear implants, or shrapnel fragments).
- Any child with permanent tattoos on the eyelids (ferromagnetic iron oxide-based) tattoo pigments can interact with the static magnetic field of an MRI imager.
- Exclusionary criteria for TMS:
- 1. Children with hearing loss (greater than 15 dB at any individual frequency) in either ear (as evaluated in the Audiology Department, CC, NIH).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Cortical Reorganization Following Pediatric Constraint-Induced Therapy
This study will examine how therapy changes the way the brain controls movements in children with cerebral palsy. Normally, one side of the brain controls movements in the opposite side of the body. In cerebral palsy, however, this pattern may be different, with one side of the brain controlling movements on the same side of the body. This study will use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) to study brain function in children with cerebral palsy before and after therapy.
Children between 9 and 17 years of age with spastic hemiplegia type cerebral palsy will be recruited for this study from the National Rehabilitation Hospital and Georgetown University Center Medical Center in Washington, D.C., and the Sparks Center at UAB in Alabama. In addition, five healthy control children will be recruited from community groups, such as Cub Scouts, Brownies, and schools. Candidates are screened with a review of medical records and neurological and physical examinations.
Read more
Healthy controls undergo MRI (described below) twice, 3 weeks apart. Children with cerebral palsy undergo the following tests and procedures:
- Rehabilitation evaluation at the NIH Clinical Center Rehabilitation Medicine Department.
- MRI: For this test, the child lies on a table that slides in and out of the MRI scanner-a metal cylinder surrounded by a strong magnetic field. He or she wears earplugs to muffle loud knocking sounds that occur during scanning. Images are obtained while the child performs simple finger tapping movements.
- Movement Testing:
- Finger tapping: The child taps buttons on a box hooked up to a computer
- Muscle reflex measurements: One method uses a small motor that makes the child's fingers move with sudden, small movements; a second method uses small shocks to the finger or wrist. The shocks feel like a buzz; most are gentle, but some might feel stronger.
- TMS: This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the child may be asked to perform simple movements.. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the child may hear a click and feel a pulling sensation on the skin under the coil.
- Therapy: After these tests, children are randomly selected to receive either standard therapy (neurodevelopmental treatment) or constraint-induced therapy, as follows:
- Neurodevelopmental therapy uses principles of movement science to enhance the child's capacity to function. The child receives therapy a few times a week for 3 weeks.
- Constraint-induced therapy uses a combination of motor learning method and constraint to teach the new motor skills in the child's affected hand. Children treated with this therapy must live near a special treatment center in Alabama for the 3 weeks of treatment. The child's good arm is constrained with a bivalve, removable cast. The cast is placed before therapy starts and remains in place except when the therapist removes it once a day to examine the good arm. With the cast on, children are encouraged to use their affected hand in new ways. The therapist then uses the motor learning method, building motor programs as a result of practice, to teach them new skills. Motor learning therapy is 6 hours a day.
- Post-treatment testing: After treatment, children undergo repeat rehabilitation assessment, MRI, TMS, and movement testing.
Read the detailed description
Objective: To determine the underlying brain reorganization that occurs in children with hemiplegic cerebral palsy before and after pediatric Constraint-Induced therapy.
Background: A promising new therapy for adults with hemiparesis consequent to stroke, known as Constraint-Induced Movement (CI) therapy, has recently been modified for use in children with cerebral palsy. Children with cerebral palsy treated with CI therapy show significant gains in motor skills after receiving this intensive and extended treatment.
There is evidence to suggest that, after an acute stroke in adults, the undamaged motor cortex exerts greater control over movements in the affected hand than is normally seen in neurologically intact subjects. While this might seem to be an advantage, combined functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) studies demonstrate that it is associated with poor motor recovery in adults after a stroke and impaired hand function in patients with cerebral palsy. Thus, anomalous motor control of the affected hand by the unaffected cortex may reflect a less efficient cortical reorganization process.
There is controversy about how CI therapy produces an improvement in motor function. Conflicting evidence from fMRI and TMS studies in adult patients with stroke have shown that patients may have either an increase in ipsilateral motor cortical activation or an increase in activation in the damaged hemisphere. The answer to this controversy may be related to the presence of ipsilateral projections. Since ipsilateral projections are associated with worse functional outcome, determining the type of response to CI therapy may give insights into those patients who need more intense therapy.
Subject Population: Children with hemiplegic subtype of cerebral palsy; age-matched children with no neurological abnormalities
Design: We will assess motor cortex activation before and after CI therapy using fMRI and neurophysiologic tests including TMS and muscle reflex studies in children with hemiplegic cerebral palsy with and without evidence for ipsilateral projections.
Outcome measures: Patients will be stratified by the presence of mirror movements. Primary outcome measure will be laterality index on cortical activation of the fMRI before and after CI therapy. Secondary outcome measures will be standardized measures of sensory and motor function. We will examine the relationship between the presence of anomalous ipsilateral motor control and cortical reorganization following CI therapy.
Significance: Understanding this relationship is essential for planning large randomized controlled trials. Since anomalous ipsilateral cortical reorganization reflects an inefficient cortical reorganization process, treatment outcome of CI therapy may also be worse in this group. In this case, future studies may need to stratify children on study entry according to types of brain reorganization.
- Conditions
- Cerebral Palsy
- Keywords
- Rehabilitation, Forced Use, Hemiplegia, Magnetic Resonance Imaging, TMS, Cerebral Palsy, Spastic Hemiplegia, Healthy Volunteer, HV
- Medical subject headings
- Cerebral Palsy, Hemiplegia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2005 (estimated)
- Study start27 Dec 2004
- Study completion30 Aug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100503
- Sponsor's protocol ID
- 050066
- Other IDs
- 05-N-0066
- Status last verified
- 30 Aug 2006
- First submitted
- 31 Dec 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Carr LJ, Harrison LM, Evans AL, Stephens JA. Patterns of central motor reorganization in hemiplegic cerebral palsy. Brain. 1993 Oct;116 ( Pt 5):1223-47. doi: 10.1093/brain/116.5.1223.
PubMed 8221056
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Reorganization Following Pediatric Constraint-Induced Therapy
- ClinicalTrials.gov ID
- NCT00100503
- Acronym / sponsor ID
- 050066
- Conditions
- Cerebral Palsy
- Keywords
- Rehabilitation, Forced Use, Hemiplegia, Magnetic Resonance Imaging, TMS, Cerebral Palsy, Spastic Hemiplegia, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 27 Dec 2004
- Study completion
- 30 Aug 2006
- First posted
- 3 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine how therapy changes the way the brain controls movements in children with cerebral palsy. Normally, one side of the brain controls movements in the opposite side of the body. In cerebral palsy, however, this pattern may be different, with one side of the brain controlling movements on the same side of the body. This study will use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) to study brain function in children with cerebral palsy before and after therapy.
Children between 9 and 17 years of age with spastic hemiplegia type cerebral palsy will be recruited for this study from the National Rehabilitation Hospital and Georgetown University Center Medical Center in Washington, D.C., and the Sparks Center at UAB in Alabama. In addition, five healthy control children will be recruited from community groups, such as Cub Scouts, Brownies, and schools. Candidates are screened with a review of medical records and neurological and physical examinations.
Healthy controls undergo MRI (described below) twice, 3 weeks apart. Children with cerebral palsy undergo the following tests and procedures:
- Rehabilitation evaluation at the NIH Clinical Center Rehabilitation Medicine Department.
- MRI: For this test, the child lies on a table that slides in and out of the MRI scanner-a metal cylinder surrounded by a strong magnetic field. He or she wears earplugs to muffle loud knocking sounds that occur during scanning. Images are obtained while the child performs simple finger tapping movements.
- Movement Testing:
- Finger tapping: The child taps buttons on a box hooked up to a computer
- Muscle reflex measurements: One method uses a small motor that makes the child's fingers move with sudden, small movements; a second method uses small shocks to the finger or wrist. The shocks feel like a buzz; most are gentle, but some might feel stronger.
- TMS: This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the child may be asked to perform simple movements.. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the child may hear a click and feel a pulling sensation on the skin under the coil.
- Therapy: After these tests, children are randomly selected to receive either standard therapy (neurodevelopmental treatment) or constraint-induced therapy, as follows:
- Neurodevelopmental therapy uses principles of movement science to enhance the child's capacity to function. The child receives therapy a few times a week for 3 weeks.
- Constraint-induced therapy uses a combination of motor learning method and constraint to teach the new motor skills in the child's affected hand. Children treated with this therapy must live near a special treatment center in Alabama for the 3 weeks of treatment. The child's good arm is constrained with a bivalve, removable cast. The cast is placed before therapy starts and remains in place except when the therapist removes it once a day to examine the good arm. With the cast on, children are encouraged to use their affected hand in new ways. The therapist then uses the motor learning method, building motor programs as a result of practice, to teach them new skills. Motor learning therapy is 6 hours a day.
- Post-treatment testing: After treatment, children undergo repeat rehabilitation assessment, MRI, TMS, and movement testing.
Detailed description
Objective: To determine the underlying brain reorganization that occurs in children with hemiplegic cerebral palsy before and after pediatric Constraint-Induced therapy.
Background: A promising new therapy for adults with hemiparesis consequent to stroke, known as Constraint-Induced Movement (CI) therapy, has recently been modified for use in children with cerebral palsy. Children with cerebral palsy treated with CI therapy show significant gains in motor skills after receiving this intensive and extended treatment.
There is evidence to suggest that, after an acute stroke in adults, the undamaged motor cortex exerts greater control over movements in the affected hand than is normally seen in neurologically intact subjects. While this might seem to be an advantage, combined functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) studies demonstrate that it is associated with poor motor recovery in adults after a stroke and impaired hand function in patients with cerebral palsy. Thus, anomalous motor control of the affected hand by the unaffected cortex may reflect a less efficient cortical reorganization process.
There is controversy about how CI therapy produces an improvement in motor function. Conflicting evidence from fMRI and TMS studies in adult patients with stroke have shown that patients may have either an increase in ipsilateral motor cortical activation or an increase in activation in the damaged hemisphere. The answer to this controversy may be related to the presence of ipsilateral projections. Since ipsilateral projections are associated with worse functional outcome, determining the type of response to CI therapy may give insights into those patients who need more intense therapy.
Subject Population: Children with hemiplegic subtype of cerebral palsy; age-matched children with no neurological abnormalities
Design: We will assess motor cortex activation before and after CI therapy using fMRI and neurophysiologic tests including TMS and muscle reflex studies in children with hemiplegic cerebral palsy with and without evidence for ipsilateral projections.
Outcome measures: Patients will be stratified by the presence of mirror movements. Primary outcome measure will be laterality index on cortical activation of the fMRI before and after CI therapy. Secondary outcome measures will be standardized measures of sensory and motor function. We will examine the relationship between the presence of anomalous ipsilateral motor control and cortical reorganization following CI therapy.
Significance: Understanding this relationship is essential for planning large randomized controlled trials. Since anomalous ipsilateral cortical reorganization reflects an inefficient cortical reorganization process, treatment outcome of CI therapy may also be worse in this group. In this case, future studies may need to stratify children on study entry according to types of brain reorganization.
Study design
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Scores below 60 on Connor's attention deficit/hyperactivity disorder (ADHD) checklist.
- Normal neurological history and examination
Key exclusion criteria (17 listed)
- Any child who is pregnant
- Patients with Development Quotient (DQ) or Intelligence Quotient (IQ) below 50 on standardized tests
- Children with subtypes of cerebral palsy that are not hemiplegia.
- Children with uncontrolled seizures within the last 6 months
- Children with progressive or neurodegenerative disorders; underlying known genetic or chromosomal disorders, familial or non-familial syndromes (without known chromosomal or genetic defect)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8221056Carr LJ, Harrison LM, Evans AL, Stephens JA. Patterns of central motor reorganization in hemiplegic cerebral palsy. Brain. 1993 Oct;116 ( Pt 5):1223-47. doi: 10.1093/brain/116.5.1223.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.