NCT01037361

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2009

Typical duration 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

December 2, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2012

Completed
Last Updated

December 17, 2019

Status Verified

June 29, 2012

First QC Date

December 19, 2009

Last Update Submit

December 14, 2019

Conditions

Keywords

Children and AdolescentsMotor ControlMovement-Related PotentialStereotypic Movement DisorderElectroencephalogram (EEG)

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 11055459BACKGROUND
  • Castellanos 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.

    PMID: 8617696BACKGROUND
  • Deecke L. Electrophysiological correlates of movement initiation. Rev Neurol (Paris). 1990;146(10):612-9.

    PMID: 2263824BACKGROUND

MeSH Terms

Conditions

Movement DisordersStereotypic Movement Disorder

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Beth A Belluscio, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

December 19, 2009

First Posted

December 23, 2009

Study Start

December 2, 2009

Study Completion

June 29, 2012

Last Updated

December 17, 2019

Record last verified: 2012-06-29

Locations