Cerebellar Loops and Attention Deficit Hyperactivity Diso... | NCT00684931

Studies
Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD)

NCT00684931

Sponsor

University Hospital, Bordeaux

Status

Terminated

Last Update Posted

Jun 23, 2009Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Imaging

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties in the organisation

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

May 22, 2008

First Submission Date that Met QC Criteria

May 22, 2008

First Posted Date

May 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2009

Last Update Posted Date

Jun 23, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Imaging	Other	neuropsychological evaluation and Imaging with magnetic resonance (MRI)	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fractional anisotropy coefficient if fronto-cerebello-frontal loops.		visite 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel BOUVARD, MD	Charles Perrens Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charles Perrens Hospital		Bordeaux		33000	France
University Hospital Bordeaux

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D004194	Disease
D013035	Spasm

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided