Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001915
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Study of Attention DeficitHyperactivity Disorder Using Transcranial Magnetic Stimulation
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cortical Correlates of Subtle Motor Signs in Attention-DeficitHyperactivity Disorder and Healthy Controls
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Attention deficithyperactivity disorder is a condition characterized by a decreased attention span hyperactivity andor 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 patients 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
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 patients 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
Detailed Description:
Subtle neurological signs synkinesis and mirror movements are present in normal children up until 9 or 10 years of age In addition speed of repetitive and sequential movements increases from 5 to 8 years of age at which time children perform these movements at close to adult speeds Based on clinical studies of both normal children and of children with corticospinal tract lesions it has been postulated that these subtle motor signs reflect neurodevelopmental immaturity of the intracortical and interhemispheric inhibitory systems and that their disappearance occurs as a result of maturation
The presence of subtle neurological signs can accurately distinguish children with attention-deficithyperactivity disorder ADHD from healthy controls The increased intensity of these neurological signs in younger age groups and their persistence beyond the age of 9 years suggest that children with ADHD may have delayed or abnormal neuromaturational development in particular development of the inhibitory systems of the motor cortex This is in concert with the theories of cognitive abnormalities seen in these children where behavioral studies indicate that children with ADHD have most difficulty in executive function tests that look specifically at motor inhibition
Transcranial magnetic stimulation TMS is a non-invasive tool which gives information about cortical function It is particularly useful in the study of the motor cortex and its connections via the corticospinal tract and the corpus callosum A single suprathreshold stimulus to the motor cortex produces a motor evoked potential MEP and inhibition of ongoing muscle activity in ipsilateral and contralateral target muscles TMS studies have demonstrated differences in both the velocity of central motor conduction and the ability to evoke motor inhibition when comparing adults with children under 10 years of age These differences suggest that cortical inhibitory and facilitatory systems undergo normal developmental changes during the first decade of life and that they may form the neural substrate for the clinical developmental changes that occur in children during this same period of time
We propose to study children with ADHD with single and paired pulse TMS to determine if the clinical abnormalities present in these children reflect an underlying delay or abnormality in maturation of the inhibitory and facilitatory systems of the cortex and corticospinal tracts If present these findings would give objective evidence of abnormal inhibitory systems in attention-deficithyperactivity disorder their presence or absence may differentiate between the different subtypes of ADHD Since stimulants have an ameliorative effect on the neuropsychological functioning in these children future studies would be able to determine whether they have a similar effect on the motor system
TMS is associated with a click which can have a 120 dB peak sound level at maximum stimulator output Studies in adults and children have shown no long-lasting or permanent hearing loss after TMS but there is no information regarding transient decrease in hearing thresholds immediately after TMS as can occur after listening to music through headphones using personal cassette recorders As part of the main study we will be conducting a safety study to determine the risk for temporary hearing loss after TMS in children
The presence of subtle neurological signs can accurately distinguish children with attention-deficithyperactivity disorder ADHD from healthy controls The increased intensity of these neurological signs in younger age groups and their persistence beyond the age of 9 years suggest that children with ADHD may have delayed or abnormal neuromaturational development in particular development of the inhibitory systems of the motor cortex This is in concert with the theories of cognitive abnormalities seen in these children where behavioral studies indicate that children with ADHD have most difficulty in executive function tests that look specifically at motor inhibition
Transcranial magnetic stimulation TMS is a non-invasive tool which gives information about cortical function It is particularly useful in the study of the motor cortex and its connections via the corticospinal tract and the corpus callosum A single suprathreshold stimulus to the motor cortex produces a motor evoked potential MEP and inhibition of ongoing muscle activity in ipsilateral and contralateral target muscles TMS studies have demonstrated differences in both the velocity of central motor conduction and the ability to evoke motor inhibition when comparing adults with children under 10 years of age These differences suggest that cortical inhibitory and facilitatory systems undergo normal developmental changes during the first decade of life and that they may form the neural substrate for the clinical developmental changes that occur in children during this same period of time
We propose to study children with ADHD with single and paired pulse TMS to determine if the clinical abnormalities present in these children reflect an underlying delay or abnormality in maturation of the inhibitory and facilitatory systems of the cortex and corticospinal tracts If present these findings would give objective evidence of abnormal inhibitory systems in attention-deficithyperactivity disorder their presence or absence may differentiate between the different subtypes of ADHD Since stimulants have an ameliorative effect on the neuropsychological functioning in these children future studies would be able to determine whether they have a similar effect on the motor system
TMS is associated with a click which can have a 120 dB peak sound level at maximum stimulator output Studies in adults and children have shown no long-lasting or permanent hearing loss after TMS but there is no information regarding transient decrease in hearing thresholds immediately after TMS as can occur after listening to music through headphones using personal cassette recorders As part of the main study we will be conducting a safety study to determine the risk for temporary hearing loss after TMS in children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-N-0034 | None | None | None |