Cerebral Palsy Clinical Trial
Official title:
Cortical Reorganization Following Pediatric Constraint-Induced Therapy
Verified date | August 30, 2006 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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:
1. Rehabilitation evaluation at the NIH Clinical Center Rehabilitation Medicine Department.
2. 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.
3. Movement Testing:
1. Finger tapping: The child taps buttons on a box hooked up to a computer
2. 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.
4. 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.
5. Therapy: After these tests, children are randomly selected to receive either standard
therapy (neurodevelopmental treatment) or constraint-induced therapy, as follows:
1. 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.
2. 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.
6. Post-treatment testing: After treatment, children undergo repeat rehabilitation
assessment, MRI, TMS, and movement testing.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 30, 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility |
- INCLUSION CRITERIA: 1. Children 9 to 17 years of age. Cerebral palsy patients: 2. Children previously diagnosed with spastic hemiplegia subtype of cerebral palsy 3. Children with non-progressive cerebral lesions acquired pre-, peri- or post-natally, before 1 year of age. Typically Developing subjects: 1. Scores below 60 on Connor's attention deficit/hyperactivity disorder (ADHD) checklist. 2. Normal neurological history and examination EXCLUSION CRITERIA: 1. Any child who is pregnant 2. Patients with Development Quotient (DQ) or Intelligence Quotient (IQ) below 50 on standardized tests Cerebral palsy patients: 3. Children with subtypes of cerebral palsy that are not hemiplegia. 4. Children with uncontrolled seizures within the last 6 months 5. Children with progressive or neurodegenerative disorders; underlying known genetic or chromosomal disorders, familial or non-familial syndromes (without known chromosomal or genetic defect) 6. Patients with cerebral lesions caused by sickle cell disease or by emboli associated with congenital cardiac lesions 7. Patients incapable of voluntary movement or with severe cognitive deficits who cannot follow simple verbal commands Typically Developing Children: 1. Children with chronic medical disorders or any neurological and /or psychiatric disorder including attention deficit hyperactivity disorder or learning disorder 2. Children taking regular medications, including medications for allergies, hormonal oral contraceptives, or over-the-counter medications 3. 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: 1. 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). 2. 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). |
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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. — View Citation
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