- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00024791
Eye-Hand Coordination in Children With Spastic Diplegia
Neurophysiology of Motor Disorders in Spastic Diplegia
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. doi: 10.1016/s0006-3223(99)00131-6.
- 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. doi: 10.1212/wnl.47.2.477.
- Andres FG, Gerloff C. Coherence of sequential movements and motor learning. J Clin Neurophysiol. 1999 Nov;16(6):520-7. doi: 10.1097/00004691-199911000-00004.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010260
- 01-N-0260
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diplegia, Spastic
-
Cairo UniversityUnknownSpastic Diplegia Cerebral PalsyEgypt
-
Thammasat UniversityNational Research Council of ThailandCompletedChildren With Spastic Diplegia, Between the Ages of 2 to 10 Years | Gross Motor Function Classification System (GMFCS) Level I,II and IIIThailand
-
Riphah International UniversityCompletedSpastic DiplegiaPakistan
-
Universitat de LleidaNot yet recruitingCerebral Palsy, SpasticSpain
-
Riphah International UniversityRecruitingCerebral Palsy Spastic DiplegiaPakistan
-
Cairo UniversityNot yet recruitingCerebral Palsy | Spastic Diplegia
-
Cairo UniversityRecruiting
-
National Taiwan University HospitalUnknownCerebral Palsy | Spastic DiplegiaTaiwan
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Riphah International UniversityRecruitingCerebral Palsy Spastic DiplegiaPakistan