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| Tracking Information | |||||
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| First Received Date ICMJE | May 22, 2008 | ||||
| Last Updated Date | June 22, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Fractional anisotropy coefficient if fronto-cerebello-frontal loops. [ Time Frame: visite 1 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00684931 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD) | ||||
| Official Title ICMJE | Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI) | ||||
| Brief Summary | The aim of this study is to investigate the integrity of connectivity between the neocortex and the cerebellum in the Attention Deficit Hyperactivity Disorder (ADHD). Fibers integrity will be measured using magnetic Resonance Imaging Techniques. |
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| Detailed Description | ADHD is a neurodevelopmental trouble characterized by attentional deficits, impulsivity and motor hyperactivity. Morphological neuroimaging studies in ADHD children have revealed cerebellar abnormalities, however data in adults regarding cerebellum alterations are scarce. In this study we will analyse the conectivity of the cerebellum of adults ADHD patients. We will use diffusion tensor imaging (DTI) technique, and morphological data will be compared with the neuropsychological status. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Basic Science, Non-Randomized, Open Label, Parallel Assignment | ||||
| Condition ICMJE | Attention Deficit Disorder With Hyperactivity | ||||
| Intervention ICMJE | Other: Imaging | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 19 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patient with ADHD :
Healthy volunteer :
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00684931 | ||||
| Responsible Party | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux | ||||
| Study ID Numbers ICMJE | CHUBX 2007/21 | ||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Bordeaux | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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