NIH Clinical Research Studies

Protocol Number: 01-N-0260

Active Accrual, Protocols Recruiting New Patients

Title:
Neurophysiology of Motor Disorders in Spastic Diplegia
Number:
01-N-0260
Summary:
This study will examine how the brain controls eye-hand coordination (visuomotor skills) in children with spastic diplegia and will determine whether impairment of this skill is related to the learning difficulties in school that some of these children experience. Spastic diplegia is a form of cerebral palsy that affects the legs more than the hands. The brain injury causing the leg problem in this disease may also cause difficulty with eye-hand coordination.

Healthy normal volunteers and children with spastic diplegia between 6 and 12 years of age may be eligible for this study. Candidates will be screened with a review of medical and school records, psychological testing, neurological and physical examinations, and assessment of muscle function in the arms and legs.

Participants may undergo one or more of the following procedures:

Neuropsychological testing (1 to 2 hours) - involves sitting at a computer and answering questions, such as whether the letters on the screen make up a real word.

Magnetic resonance imaging (MRI) (45 minutes) - uses a strong magnetic field and radio waves to provide images of the brain. The child lies on a table in a narrow cylindrical machine while the scans are obtained. Both the child and parent wear earplugs to muffle the loud noise the radio waves make while the images are formed.

Electroencephalography (EEG) and electromyography (EMG) (1 to 2 hours) - EEG uses electrodes to record the electrical activity of the brain. The electrodes are in a special cap that is worn on the head during the procedure. EMG records electrical activity from muscles. Electrodes are placed on the skin over certain muscles. During the test, the child makes simple repetitive movements, such as finger tapping. The cap and the electrodes on the skin are removed at the end of the test.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA FOR SPECIFIC AIM #1:

Children 12 to 14 years of age will be eligible for the study as neuromotor function in healthy children is close to adult levels at this age.

Diplegic children must have been born before 36 weeks gestation with a birth weight appropriate for their gestational age.

Clinical examination for these children must show bilateral spasticity with more severe involvement of the legs than of the arms.

Healthy subjects must be free from all neurologic and psychiatric disorders with normal scores on the Connor's attention deficit hyperactivity disorder (ADHD) checklist and the Child Behavior Check List (CBCL).

Neurological history and examination must be normal.

EXCLUSION CRITERIA FOR SPECIFIC AIM #1:

Patients with sapstic diplegia who were born at term will be excluded from the study as these form a separate diagnostic cohort.

Children with a history of a severe (grade III or IV) intraventricular hemorrhage, or periventricular hemorrhagic infarction will be excluded.

Diplegic children who have a genetic or congenital disorder (such as congenital cytomegalovirus or rubella infection) will be excluded.

Children with obviously asymmetric findings (hemiplegia) or quadriplegia (arms and legs affected equally) will also be excluded.

Healthy children will be excluded from the study if they have ADHD, obsessive compulsive symptoms, tics or any other neurologic or psychiatric disorders.

Subjects who have siblings with an undiagnosed cause of developmental delay or abnormalities of the corpus callosum will be excluded from the study.

Subjects with albinism or a personal or family history of sensorineural hearing loss have an increased incidence of incidental callosal abnormalities and for this reason will be excluded.

Diplegic subjects with a personal history of seizures and any subject with a family history of first degree relatives with seizures will be excluded from the transcranial magnetic stimulation portion of the study.

INCLUSION CRITERIA FOR SPECIFIC AIM #2:

Spastic diplegia patients and age matched healthy controls aged 7-14 years of age will be recruited using the same methods outlined in Specific Aim #1. Data from eligible 13-year-old patients and healthy controls studied in Specific Aim #1 will be included in the data analysis of this specific aim.

Spastic diplegia patients will be matched on the extent and severity of periventricular leucomalacia (PVL) on their clinical MRIs. We will study the group of patients with pathology extending from occipital to frontal regions, as this appears to be most common in diplegic children.

Healthy subjects must be free from all neurologic and psychiatric disorders with normal scores on the Connor's attention deficit hyperactivity disorder (ADHD) checklist and the Child Behavior Check List (CBCL).

Neurological history and examination must be normal.

EXCLUSION CRITERIA FOR SPECIFIC AIM #2:

These will be the same as those outlined in Specific Aim #1 for both spastic diplegia patients and healthy controls.

In addition, diplegic children with MRI lesions other than PVL (porencephaly, schizencephaly) will be excluded.

Special Instructions: Currently Not Provided
Keywords:
Cerebral Palsy
Pediatric
Cognition
Motor Learning
Visuomotor Integration
Corticospinal Tracts
Cortical Re-Organization
Spastic Hemiplegia
Spastic Diplegia
Functional Outcome
Recruitment Keywords:
Pediatric
Children
Spastic Diplegia
Cerebral Palsy
Healthy Volunteer
HV
Normal Control
Conditions:
Diplegia, Spastic
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Breslau N, Chilcoat HD, Johnson EO, Andreski P, Lucia VC.

Neurologic soft signs and low birthweight: their association and neuropsychiatric implications. Biol Psychiatry. 2000 Jan 1;47(1):71-9. PMID: 10650451

Baumgardner TL, Singer HS, Denckla MB, Rubin MA, Abrams MT, Colli MJ, Reiss AL. Corpus callosum morphology in children with Tourette syndrome and attention deficit hyperactivity disorder. Neurology. 1996 Aug;47(2):477-82. PMID: 8757024

Andres FG, Gerloff C. Coherence of sequential movements and motor learning J Clin Neurophysiol. 1999 Nov;16(6):520-7. Review. PMID: 10600020

Active Accrual, Protocols Recruiting New Patients

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