NCT00001915

Brief Summary

Attention deficit/hyperactivity disorder is a condition characterized by a decreased attention span, hyperactivity, and/or impulsiveness inappropriate for a certain age. Typically, young children have what are known as subtle neurological signs. These are involuntary movements of one part of the body that occur while the child is making a voluntary movement of another part of the body. This is referred to as synkinesis, or overflow movements. These overflow movements disappear during normal development and are usually gone by the age of 10. However, in children with ADHD these overflow movements tend to be more intense and last long after the age of 10. This leads researchers to believe there is an abnormality in the maturation and development of the brain areas associated with motor activity in children with ADHD. Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that gives information about brain function. It is very useful when studying areas of the nervous system related to motor activity (motor cortex, corticospinal tract, and corpus callosum). A magnetic signal given from a special instrument held close to the patient's head stimulates a small area of the brain that controls a few muscles (for example, the muscles that control one finger). Doctors put electrodes (small pieces of metal taped to areas of the body) over the muscle to measure the electrical activity the muscle produces when it makes a movement. When the magnetic signal activates those muscles the electrodes pick up and record the electrical activity of the movement that the muscles make in response to the magnetic signal. Researchers will study normal children and those diagnosed with ADHD using TMS to find out if the clinical abnormalities of ADHD are associated with a delay or abnormality in maturation of areas of the nervous system responsible for motor activity (motor cortex and corticospinal tract).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Cortical StimulationMotor ControlNeuromotor MaturationMagnetic StimulationAttention Deficit Hyperactivity DisorderHearing LossHearing ConservationHearing Protective DevicesSafety StudyNoise Induced Hearing LossNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Boys and girls 9 to 13 years of age.
  • Right handed subjects only.
  • Subjects that are off stimulant medications.
  • Children who undergo a medication washout as a part of a different study or are on a planned drug holigay will be allowed to enroll in the study once they have bee off the medications for at least 10 days.
  • Adult men with a history of ADHD between 18 and 30 years and healthy age-matched normal volunteers.

You may not qualify if:

  • Patients with neurological disorders will be excluded. In particular, persons with a personal or family history of seizures or epilepsy; structural cerebral disorders (e.g. hemiplegia or other abnormalities of the corticospinal tracts). We will also exclude from our study any persons who have a personal or family history of sensorineural loss. Person with abnormally decreased pigmentation (albinism) will also be excluded from the study.
  • Patients with a chronic motor or vocal tic disorder or Tourette Syndrome. Children with tics, not meeting DSM-III criteria for tic disorder will be allowed to enroll in the study.
  • Children with localizing neurological signs (asymmetric deep tendon reflexes (DTRs), dysmetria, hypotonia) will also be excluded.
  • Children with psychiatric disorders other than oppositional defiant disorder (ODD) will be excluded from study.
  • Children who have dyslexia and learning disabilities but do not have ADHD will be excluded.
  • Children with ADHS who are on a stimulant medication will be excluded from enrollment in the study.
  • HEALTHY CONTROLS:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Denckla MB. Development of motor co-ordination in normal children. Dev Med Child Neurol. 1974 Dec;16(6):729-41. doi: 10.1111/j.1469-8749.1974.tb03393.x. No abstract available.

    PMID: 4442654BACKGROUND
  • Denckla MB. Development of speed in repetitive and successive finger-movements in normal children. Dev Med Child Neurol. 1973 Oct;15(5):635-45. doi: 10.1111/j.1469-8749.1973.tb05174.x. No abstract available.

    PMID: 4765232BACKGROUND
  • Connolly K, Brown K, Bassett EE. Developmental changes in some components of a motor skill. Br J Psychol. 1968 Aug;59(3):305-14. doi: 10.1111/j.2044-8295.1968.tb01145.x. No abstract available.

    PMID: 5760077BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityHearing LossHearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss, Sensorineural

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

January 1, 1999

Study Completion

February 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-02

Locations