NCT00684931

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

February 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

Enrollment Period

Same day

First QC Date

May 22, 2008

Last Update Submit

June 22, 2009

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

AttentionDeficitDisorderHyperactivitycerebellumalterationfronto-cerebello-frontal loops

Outcome Measures

Primary Outcomes (1)

  • Fractional anisotropy coefficient if fronto-cerebello-frontal loops.

    visite 1

Study Arms (2)

1

EXPERIMENTAL

patients with Attention Deficit Disorder with or without Hyperactivity

Other: Imaging

2

SHAM COMPARATOR

healthy volunteer without Attention Deficit Hyperactivity Disorder

Other: Imaging

Interventions

ImagingOTHER

neuropsychological evaluation and Imaging with magnetic resonance (MRI)

12

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with ADHD :
  • Diagnosis of ADHD
  • years old
  • Healthy volunteer :
  • years old
  • no ADHD diagnosed

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charles Perrens Hospital

Bordeaux, 33000, France

Location

University Hospital Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDiseaseSpasm

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Manuel BOUVARD, MD

    Charles Perrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 28, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2008

Study Completion

July 1, 2008

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations

FR(2)