Movement DisorderNCT01037361
Cerebral Activity Related to Primary Motor Stereotypies in Children: An EEG Study.
An observational study of Movement Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorder
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2009to 29 Jun 2012
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients:
- Children will be eligible to participate if they meet the following criteria:
- Are 7 through 18 years old;
- Are identified as having complex-motor stereotypies with predominant movements consisting of repetitive arm flapping, hand waving, or finger wiggling movements (only children presenting with these movements will be included);
- Predominant stereotypic movements must have started before six years of age;
- Predominant stereotypic movements must have been present for at least four months and occur at least 10 times a day;
Show all 13Show fewer
- Dr Harvey Singer must have witnessed movements either in person or via videotape.
- The use of medication that does not affect the central nervous system will be allowed during the study.
- Subjects with the diagnosis of ADHD, obsessive-compulsive disorder, conduct disorder, or learning disability can be included.
- Healthy volunteers:
- Children will be eligible to participate if they meet the following criteria:
- Are 7 through 18 years old;
- Are able to give informed assent.
Who cannot join
- Patients:
- Subjects will be excluded from this study if there is:
- Diagnosis of autism, autistic spectrum disorder, Asperger syndrome, Pervasive Developmental Disorder NOS, or mental retardation (IQ < 70);
- Concurrent significant medical, neurological, or psychiatric condition;
- Use of tranquilizers, psychotropic drugs or medications which could modulate the cortical activity, or if subjects have taken these medications during the month prior to their screening visit. As a consequence, children under stimulant medications for ADHD will be excluded from the study.
- Healthy volunteers:
- Abnormal neurological exam, current or past history of neurological disease or psychiatric disease. Patients with neurological diseases of the central nervous system that impair the motor system or cognitive function will be excluded;
- Use of tranquilizers, psychotropic drugs or medications which could modulate the cortical activity, or if subjects have taken these medications during the month prior to their screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Cerebral Activity Related to Primary Motor Stereotypies in Children: An EEG Study
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.
Read more
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.
Read the 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.
- Conditions
- Movement Disorder
- Keywords
- Children and Adolescents, Motor Control, Movement-Related Potential, Stereotypic Movement Disorder, Electroencephalogram (EEG)
- Medical subject headings
- Movement Disorders, Stereotypic Movement Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency and amplitude of evoked (ERPs) and induced (ERD) activity related to motor stereotypies.
Secondary outcomes (1)
Measures of latency and amplitude of evoked and induced activity related to voluntary movements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study start2 Dec 2009
- Study completion29 Jun 2012
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 Movement DisorderStudies 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
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Beth A Belluscio, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037361
- Sponsor's protocol ID
- 100015
- Other IDs
- 10-N-0015
- Status last verified
- 29 Jun 2012
- First submitted
- 19 Dec 2009
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. doi: 10.1023/a:1005596502855.
PubMed 11055459Castellanos FX, Ritchie GF, Marsh WL, Rapoport JL. DSM-IV stereotypic movement disorder: persistence of stereotypies of infancy in intellectually normal adolescents and adults. J Clin Psychiatry. 1996 Mar;57(3):116-22.
PubMed 8617696Deecke L. Electrophysiological correlates of movement initiation. Rev Neurol (Paris). 1990;146(10):612-9.
PubMed 2263824
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Activity Related to Primary Motor Stereotypies in Children: An EEG Study
- ClinicalTrials.gov ID
- NCT01037361
- Acronym / sponsor ID
- 100015
- Conditions
- Movement Disorder
- Keywords
- Children and Adolescents, Motor Control, Movement-Related Potential, Stereotypic Movement Disorder, Electroencephalogram (EEG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 2 Dec 2009
- Study completion
- 29 Jun 2012
- First posted
- 23 Dec 2009 (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.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Are 7 through 18 years old;
- Are identified as having complex-motor stereotypies with predominant movements consisting of repetitive arm flapping, hand waving, or finger wiggling movements (only children presenting with these movements will be included);
- Predominant stereotypic movements must have started before six years of age;
- Predominant stereotypic movements must have been present for at least four months and occur at least 10 times a day;
- Dr Harvey Singer must have witnessed movements either in person or via videotape.
Key exclusion criteria (8 listed)
- Diagnosis of autism, autistic spectrum disorder, Asperger syndrome, Pervasive Developmental Disorder NOS, or mental retardation (IQ < 70);
- Concurrent significant medical, neurological, or psychiatric condition;
- Use of tranquilizers, psychotropic drugs or medications which could modulate the cortical activity, or if subjects have taken these medications during the month prior to their screening visit. As a consequence, children under stimulant medications for ADHD will be excluded from the study.
- Abnormal neurological exam, current or past history of neurological disease or psychiatric disease. Patients with neurological diseases of the central nervous system that impair the motor system or cognitive function will be excluded;
- Use of tranquilizers, psychotropic drugs or medications which could modulate the cortical activity, or if subjects have taken these medications during the month prior to their screening visit.
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
Latency and amplitude of evoked (ERPs) and induced (ERD) activity related to motor stereotypies.
1 secondary outcome
Measures of latency and amplitude of evoked and induced activity related to voluntary movements.
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 17 Dec 2019.
- Background: PubMed 11055459Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. doi: 10.1023/a:1005596502855.
- Background: PubMed 8617696Castellanos FX, Ritchie GF, Marsh WL, Rapoport JL. DSM-IV stereotypic movement disorder: persistence of stereotypies of infancy in intellectually normal adolescents and adults. J Clin Psychiatry. 1996 Mar;57(3):116-22.
- Background: PubMed 2263824Deecke L. Electrophysiological correlates of movement initiation. Rev Neurol (Paris). 1990;146(10):612-9.
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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.
Beth A Belluscio, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Movement Disorder, 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 13 inclusion and 8 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 17 Dec 2019. 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.
What does the primary outcome measure?
Latency and amplitude of evoked (ERPs) and induced (ERD) activity related to motor stereotypies.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01037361, 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 17 Dec 2019.