Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-30 @ 3:36 PM
Study NCT ID:
NCT01037361
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2009-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Activity Related to Primary Motor Stereotypies in Children: An EEG Study.
Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Organization:
Study Overview
Official Title:
Cerebral Activity Related to Primary Motor Stereotypies in Children: An EEG Study
Status:
COMPLETED
Status Verified Date:
2012-06-29
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:
Background:
* Motor stereotypies are a movement disorder characterized by involuntary, repetitive, and rhythmic movements. These movements have a predictable pattern and seem purposeful, but they serve no obvious function, tend to be prolonged, and can be suppressed. Common examples of motor stereotypies include hand waving, head nodding, and body rocking.
* Researchers are interested in learning more about motor stereotypies. Many children with autism and other developmental disorders tend to exhibit these behaviors, but normal healthy children and even some adults have demonstrated motor stereotypies under certain conditions (including boredom and stress). More research is needed to determine the internal causes of and potential successful treatments for these behaviors.
Objectives:
\- To use electroencephalography (EEG) to study cerebral activity related to stereotypies in children.
Eligibility:
\- Children between 7 and 18 years of age who demonstrate stereotypy movements on a consistent basis (at least 10 times a day for at least 4 months).
Design:
* The study will require two visits to the National Institutes of Health Clinical Center.
* First visit: Outpatient screening visit to determine the child s eligibility for the study, including questionnaires for parents/guardians and a medical assessment of the stereotypies.
* Second visit: Participating children will spend 1 day in a room at the NIH Clinical Center Pediatric Day Hospital. During the visit, participants will wear a portable EEG unit to measure brain activity. For the first hour of the visit, researchers will perform movement tests to study the brain activity related to normal movements. For the rest of the day, participants may play games, watch television or movies, read, or nap, while continuing to wear the EEG to monitor brain activity related to the stereotypic movements.
* Participants will receive a small amount of compensation for their time and participation.
* Motor stereotypies are a movement disorder characterized by involuntary, repetitive, and rhythmic movements. These movements have a predictable pattern and seem purposeful, but they serve no obvious function, tend to be prolonged, and can be suppressed. Common examples of motor stereotypies include hand waving, head nodding, and body rocking.
* Researchers are interested in learning more about motor stereotypies. Many children with autism and other developmental disorders tend to exhibit these behaviors, but normal healthy children and even some adults have demonstrated motor stereotypies under certain conditions (including boredom and stress). More research is needed to determine the internal causes of and potential successful treatments for these behaviors.
Objectives:
\- To use electroencephalography (EEG) to study cerebral activity related to stereotypies in children.
Eligibility:
\- Children between 7 and 18 years of age who demonstrate stereotypy movements on a consistent basis (at least 10 times a day for at least 4 months).
Design:
* The study will require two visits to the National Institutes of Health Clinical Center.
* First visit: Outpatient screening visit to determine the child s eligibility for the study, including questionnaires for parents/guardians and a medical assessment of the stereotypies.
* Second visit: Participating children will spend 1 day in a room at the NIH Clinical Center Pediatric Day Hospital. During the visit, participants will wear a portable EEG unit to measure brain activity. For the first hour of the visit, researchers will perform movement tests to study the brain activity related to normal movements. For the rest of the day, participants may play games, watch television or movies, read, or nap, while continuing to wear the EEG to monitor brain activity related to the stereotypic movements.
* Participants will receive a small amount of compensation for their time and participation.
Detailed Description:
Objective
Motor stereotypy is a common movement disorder observed in children and adolescents but whose pathophysiology is unknown. Therefore, our overall objective is to study cerebral activity related to stereotypies. First, we want to define whether motor stereotypies are preceded by a cortical potential, as it is observed before voluntary movements. We hypothesize that no pre-movement potentials will precede the stereotypies. However, if a pre-movement potential is observed, our secondary objective is to compare this potential to cortical potentials that precede voluntary movements. We also aim to study cortical potentials preceding voluntary movements in healthy children and to compare them with the potentials observed in children with stereotypies.
Study population
12 children presenting with primary motor stereotypies and 12 healthy children.
Design
Using 19 scalp electrodes, we will record the patients electroencephalographic (EEG) activity for up to 8 hours during one day. The electromyographic (EMG) activity of the muscles involved in the stereotypies will be recorded with surface EMG electrodes. Healthy children will undergo an EEG for 2 hours. During this EEG recording, they will be asked to perform arms movements.
Outcome measures
Primary outcomes: latency and amplitude of both evoked and induced activity (cortical potentials) related to motor stereotypies will be measured.
Secondary outcomes: latency and amplitude of evoked and induced activity related to voluntary movements will be measured.
Motor stereotypy is a common movement disorder observed in children and adolescents but whose pathophysiology is unknown. Therefore, our overall objective is to study cerebral activity related to stereotypies. First, we want to define whether motor stereotypies are preceded by a cortical potential, as it is observed before voluntary movements. We hypothesize that no pre-movement potentials will precede the stereotypies. However, if a pre-movement potential is observed, our secondary objective is to compare this potential to cortical potentials that precede voluntary movements. We also aim to study cortical potentials preceding voluntary movements in healthy children and to compare them with the potentials observed in children with stereotypies.
Study population
12 children presenting with primary motor stereotypies and 12 healthy children.
Design
Using 19 scalp electrodes, we will record the patients electroencephalographic (EEG) activity for up to 8 hours during one day. The electromyographic (EMG) activity of the muscles involved in the stereotypies will be recorded with surface EMG electrodes. Healthy children will undergo an EEG for 2 hours. During this EEG recording, they will be asked to perform arms movements.
Outcome measures
Primary outcomes: latency and amplitude of both evoked and induced activity (cortical potentials) related to motor stereotypies will be measured.
Secondary outcomes: latency and amplitude of evoked and induced activity related to voluntary movements will be measured.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-N-0015 | None | None | View |