Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100503
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-12-31
Brief Title:
Brain Reorganization Following Constraint-Induced Therapy in Children With Cerebral Palsy
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cortical Reorganization Following Pediatric Constraint-Induced Therapy
Status:
COMPLETED
Status Verified Date:
2006-08-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 DC 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 childs 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 childs 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 childs affected hand Children treated with this therapy must live near a special treatment center in Alabama for the 3 weeks of treatment The childs 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
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 DC 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 childs 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 childs 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 childs affected hand Children treated with this therapy must live near a special treatment center in Alabama for the 3 weeks of treatment The childs 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0066 | None | None | None |