Diplegia, SpasticNCT00024791
Eye-Hand Coordination in Children With Spastic Diplegia
An observational study of Diplegia, Spastic, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diplegia, Spastic
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
The goal of this Career Transition Award is to acquire research training in clinical and neurophysiologic dimensions of motor disorders in cerebral palsy. Dr. Mark Hallett of the Human Motor Control Section, NINDS, will act as the principal mentor for this training award. Cerebral palsy is a group of syndromes with non-progressive motor impairment resulting from a static injury to the developing brain. The processes of growth and development further complicate the motor syndromes of cerebral palsy leading to a changing clinical picture. Mirror movements in children with spastic hemiplegia are prominent in the affected hand under 10 years of age, but are more symmetric and less noticeable after this age. Investigators speculate that callosal maturation is responsible for these changes. Understanding the affect of development on motor manifestations of cerebral palsy is critical to develop effective rehabilitative strategies at each stage of life. Many children with cerebral palsy make significant contributions to society as adults, but these achievements are possible only by overcoming physical and educational impediments with effective therapeutic interventions. Research into therapeutic strategies can decrease the possibility of performing inappropriate or irreversible interventions. A major obstacle to research in this group of patients is difficulty in distinguishing between motor syndromes. Neurophysiology can help to distinguish between the specific hypertonic patterns and their contribution to the child's functional disability. The focus of the research proposed in this award is to use neurophysiologic methods to enhance our understanding of the motor disabilities of spastic diplegia and to explore the affect of development on these disorders. One set of studies, coinciding with training in the physiology of motor control, explores the more basic physiologic aspects of motor syndromes in spastic diplegia. These studies will assess diplegic children with the goal of clarifying the physiologic nature of these motor disorders and their relationship to functional status of the patients. A second set of studies examines motor skills in spastic diplegia children at different ages with the goal of defining the affect of callosal development on the motor syndromes of cerebral palsy.
- Conditions
- Diplegia, Spastic
- Keywords
- Cerebral Palsy, Pediatric, Cognition, Motor Learning, Visuomotor Integration, Corticospinal Tracts, Cortical Re-Organization, Spastic Hemiplegia, Spastic Diplegia, Functional Outcome, Children, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Cerebral Palsy, Hemiplegia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2001 (estimated)
- Study startSep 2001
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diplegia, SpasticStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 144 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024791
- Sponsor's protocol ID
- 010260
- Other IDs
- 01-N-0260
- Status last verified
- Sep 2005
- First submitted
- 27 Sep 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 10650451Baumgardner 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.
PubMed 8757024Andres 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.
PubMed 10600020
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiology of Motor Disorders in Spastic Diplegia
- ClinicalTrials.gov ID
- NCT00024791
- Acronym / sponsor ID
- 010260
- Conditions
- Diplegia, Spastic
- Keywords
- Cerebral Palsy, Pediatric, Cognition, Motor Learning, Visuomotor Integration, Corticospinal Tracts, Cortical Re-Organization, Spastic Hemiplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 2001
- Study completion
- Sep 2005
- First posted
- 28 Sep 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this Career Transition Award is to acquire research training in clinical and neurophysiologic dimensions of motor disorders in cerebral palsy. Dr. Mark Hallett of the Human Motor Control Section, NINDS, will act as the principal mentor for this training award. Cerebral palsy is a group of syndromes with non-progressive motor impairment resulting from a static injury to the developing brain. The processes of growth and development further complicate the motor syndromes of cerebral palsy leading to a changing clinical picture. Mirror movements in children with spastic hemiplegia are prominent in the affected hand under 10 years of age, but are more symmetric and less noticeable after this age. Investigators speculate that callosal maturation is responsible for these changes. Understanding the affect of development on motor manifestations of cerebral palsy is critical to develop effective rehabilitative strategies at each stage of life. Many children with cerebral palsy make significant contributions to society as adults, but these achievements are possible only by overcoming physical and educational impediments with effective therapeutic interventions. Research into therapeutic strategies can decrease the possibility of performing inappropriate or irreversible interventions. A major obstacle to research in this group of patients is difficulty in distinguishing between motor syndromes. Neurophysiology can help to distinguish between the specific hypertonic patterns and their contribution to the child's functional disability. The focus of the research proposed in this award is to use neurophysiologic methods to enhance our understanding of the motor disabilities of spastic diplegia and to explore the affect of development on these disorders. One set of studies, coinciding with training in the physiology of motor control, explores the more basic physiologic aspects of motor syndromes in spastic diplegia. These studies will assess diplegic children with the goal of clarifying the physiologic nature of these motor disorders and their relationship to functional status of the patients. A second set of studies examines motor skills in spastic diplegia children at different ages with the goal of defining the affect of callosal development on the motor syndromes of cerebral palsy.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 10650451Breslau 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.
- Background: PubMed 8757024Baumgardner 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.
- Background: PubMed 10600020Andres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diplegia, Spastic, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00024791, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.