NCT00076596

Brief Summary

This study will examine how the brain controls movements in patients with certain types of cerebral palsy. In healthy people, one side of the body usually controls movements on the other side of the body. In patients with cerebral palsy, this pattern may be altered, and one side of the brain may control movements on the same side of the body. Information obtained from this study may lead to improved rehabilitation therapy strategies for patients with cerebral palsy. Healthy volunteers and patients with cerebral palsy between 6 and 18 years of age may be eligible for this study. All candidates will be screened with a medical history, physical examination, and psychological testing. In addition, patients with cerebral palsy will have hearing and vision tests, a review of their medical records, and a magnetic resonance imaging (MRI) scan if one has not been done within the past year. For this test, the patient lies on a table that slides into a narrow metal cylinder with a strong magnetic field (the scanner). The scanning time usually lasts between 45 and 90 minutes. Patients enrolled in the study also will be evaluated by a physiatrist and physical and occupational therapists. They will be examined for muscle stiffness and reflexes. Their gait and movements (e.g., how they pick up a glass of water) will be evaluated. They will be asked about their ability to perform activities around the house and at school and whether a wheelchair or walker is needed to get around. Patients may also be asked about how they are dealing with their movement problems and how it affects their caregivers. All participants will undergo three tests, described below, to evaluate movement control. The first two tests use electrodes (small metal discs) taped to the skin over the muscles in both hands to measure muscle activity. A small disc placed on the fingers detects and measures the hand movements. The third test uses magnetic pulses that stimulate the brain to study how the brain controls movements.

  1. 1.Quantitative test of fine motor function: For this test, the subject taps buttons at different speeds on a box attached to a computer. The test is similar to playing simple computer games.
  2. 2.Long latency reflexes: For this test, the subject's hand is lightly strapped into a holder that holds the hand still while a motor moves the index finger with sudden small movements. These reflexes may also be tested using a gentle shock to the finger delivered through a ring electrode.
  3. 3.Transcranial magnetic stimulation: For this test, the subject sits in a comfortable chair. An insulated coil is held on the scalp. A magnetic pulse from the coil stimulates the brain. The subject may hear a click and feel a snap or pulling sensation on the scalp under the coil. The stimulation may also cause twitching in the muscles of the arm or leg. During the stimulation, the subject may be asked to move certain muscles or perform other simple actions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2004

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2004

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 10, 2007

First QC Date

January 26, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

Corticospinal TractsSpastic HemiplegiaSpastic DiplegiaCortical Re-OrganizationFunctional OutcomeCerebral Palsy

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children and adults 6 to 30 years of age.
  • CEREBRAL PALSY PATIENTS:
  • Patients previously diagnosed with spastic diplegia or spastic hemiplegia subtype of cerebral palsy.
  • Lesions must be pre-, peri- or post-natal and acquired before 1 year of age.
  • Lesions must be non-progressive.
  • Patients must be able to voluntarily move their upper and lower limbs.
  • Cognitive function: DQ over 50 or IQ over 50 as assessed by Gesell or with standardized tests (pre-school age), or through school testing (school age).
  • Able to attend, at minimum, one-on-one tutoring or special education classes (to ensure cooperation with testing procedures).
  • Able to ambulate either independently or with assistive mobility devices.
  • HEALTHY SUBJECTS:
  • Scores below 60 on Connor's (ADHD) checklist.
  • Normal neurological history and examination.

You may not qualify if:

  • Any child who is pregnant. Adult women and girls between 12 and 17 years of age who have started their menstrual periods will be required to take a pregnancy test at the initial interview. If this is positive, they will not be allowed to take part in the study. At the initial phone screening we will inform both the parent/ guardian and the child that we will require this pregnancy test at the initial interview to determine eligibility and that we will inform both the child and her parents with the results of the test.
  • CEREBRAL PALSY PATIENTS:
  • Patients with subtypes of cerebral palsy that are not hemiplegia or diplegia. These include spastic quadriplegia (no difference in level of severity of motor deficit between arms and legs); spastic triplegia; mixed forms of cerebral palsy; athetoid or dystonic forms of cerebral palsy; unclassifiable forms of cerebral palsy.
  • Hemiplegic cerebral palsy with greater than minimal motor deficits on the good hand.
  • Spastic diplegia patients who have asymmetry of the motor deficit greater than 1 severity point between the two sides (e.g. left side mild, right side severe).
  • Patients with DQ or IQ below 50 as assessed by Gesell or with standardized tests (pre-school age), or through school testing (school age).
  • Uneducable patients by reason of severely impaired attention.
  • Patients with seizures within the last 6 months.
  • Patients with an underlying known genetic or chromosomal disorder.
  • Patients with clearly identified familial or non-familial syndromes (without known chromosomal or genetic defect).
  • Cerebral lesions acquired after 1 year of age.
  • Patients with progressive or neurodegenerative disorders.
  • Patient with spinal disorders in the absence of cerebral lesions.
  • Patients with cerebral lesions caused by sickle cell disease or by emboli associated with congenital cardiac lesions.
  • Patients with severe cognitive deficits who cannot follow simple verbal commands.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Location

Related Publications (1)

  • Staudt M, Grodd W, Gerloff C, Erb M, Stitz J, Krageloh-Mann I. Two types of ipsilateral reorganization in congenital hemiparesis: a TMS and fMRI study. Brain. 2002 Oct;125(Pt 10):2222-37. doi: 10.1093/brain/awf227.

    PMID: 12244080BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 26, 2004

First Posted

January 27, 2004

Study Start

January 23, 2004

Study Completion

December 10, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-10

Locations