Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT01037361
Eligibility Criteria:
* Population
12 children presenting with primary motor stereotypies will be recruited as well as 12 healthy children.
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT01037361
Study Brief:
Protocol Section:
NCT01037361