Brain Reorganization Following Constraint-Induced Therapy in Children With Cerebral Palsy

Completed

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID: NCT00100503
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 50
Starts: 2004-12-27
Expected to finish: 2006-08-30
Last updated by the study team: 2017-07-02

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

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)
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:
Children with hearing loss (greater than 15 dB at any individual frequency) in either ear (as evaluated in the Audiology Department, CC, NIH).

Where it is running

National Institute of Neurological Disorders and Stroke (NINDS) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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