NCT00100503

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

Completed Last updated 2 July 2017

What this trial tests

trial in Cerebral Palsy in 50 participants. Completed in 30 August 2006.

Timeline

27 December 2004

30 August 2006

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	27 December 2004
Estimated completion	30 August 2006
Sites	1 location across United States

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 7 to 17, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.