Cerebral Palsy Clinical Trial
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.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05317234 -
Genetic Predisposition in Cerebral Palsy
|
N/A | |
Recruiting |
NCT05576948 -
Natural History of Cerebral Palsy Prospective Study
|
||
Completed |
NCT04119063 -
Evaluating Wearable Robotic Assistance on Gait
|
Early Phase 1 | |
Completed |
NCT03264339 -
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
|
N/A | |
Completed |
NCT05551364 -
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT03902886 -
Independent Walking Onset of Children With Cerebral Palsy
|
||
Recruiting |
NCT05571033 -
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
|
N/A | |
Not yet recruiting |
NCT04081675 -
Compliance in Children With Cerebral Palsy Supplied With AFOs
|
||
Completed |
NCT02167022 -
Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy
|
N/A | |
Completed |
NCT04012125 -
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
|
N/A | |
Enrolling by invitation |
NCT05619211 -
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
|
Phase 1 | |
Completed |
NCT04489498 -
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
|
||
Completed |
NCT03677193 -
Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
|
N/A | |
Recruiting |
NCT06450158 -
Robot-assisted Training in Children With CP
|
N/A | |
Completed |
NCT04093180 -
Intensive Neurorehabilitation for Cerebral Palsy
|
N/A | |
Completed |
NCT02909127 -
The Pediatric Eating Assessment Tool
|
||
Not yet recruiting |
NCT06377982 -
Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy
|
Phase 1 | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Not yet recruiting |
NCT03183427 -
Corpus Callosum Size in Patients With Pineal Cyst
|
N/A | |
Active, not recruiting |
NCT03078621 -
Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy
|
Phase 1/Phase 2 |