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Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD) (TDA/H)

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Imaging
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention, Deficit, Disorder, Hyperactivity, cerebellum, alteration, fronto-cerebello-frontal loops

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient with ADHD :

  • Diagnosis of ADHD
  • 18 - 35 years old

Healthy volunteer :

  • 18 - 35 years old
  • no ADHD diagnosed

Exclusion Criteria:

  • Associated neurological or psychiatric pathologies
  • Pregnant woman
  • MRI counter indication

Sites / Locations

  • Charles Perrens Hospital
  • University Hospital Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

patients with Attention Deficit Disorder with or without Hyperactivity

healthy volunteer without Attention Deficit Hyperactivity Disorder

Outcomes

Primary Outcome Measures

Fractional anisotropy coefficient if fronto-cerebello-frontal loops.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2008
Last Updated
June 22, 2009
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00684931
Brief Title
Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD)
Acronym
TDA/H
Official Title
Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in the organisation
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention, Deficit, Disorder, Hyperactivity, cerebellum, alteration, fronto-cerebello-frontal loops

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
patients with Attention Deficit Disorder with or without Hyperactivity
Arm Title
2
Arm Type
Sham Comparator
Arm Description
healthy volunteer without Attention Deficit Hyperactivity Disorder
Intervention Type
Other
Intervention Name(s)
Imaging
Intervention Description
neuropsychological evaluation and Imaging with magnetic resonance (MRI)
Primary Outcome Measure Information:
Title
Fractional anisotropy coefficient if fronto-cerebello-frontal loops.
Time Frame
visite 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient with ADHD : Diagnosis of ADHD 18 - 35 years old Healthy volunteer : 18 - 35 years old no ADHD diagnosed Exclusion Criteria: Associated neurological or psychiatric pathologies Pregnant woman MRI counter indication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel BOUVARD, MD
Organizational Affiliation
Charles Perrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles Perrens Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
University Hospital Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD)

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