Attention Deficit Disorder With HyperactivityTDA/HNCT00684931
Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Imaging in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Imaging
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2008to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient with ADHD :
- Diagnosis of ADHD
- 18 - 35 years old
- Healthy volunteer :
- 18 - 35 years old
- no ADHD diagnosed
Who cannot join
- Associated neurological or psychiatric pathologies
- Pregnant woman
- MRI counter indication
Trial locations and contacts
2 sites in 1 country.
France2 sites
Charles Perrens Hospital
Bordeaux, 33000
University Hospital Bordeaux
Bordeaux, 33076
About this study
Official title: Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI)
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.
Read the 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.
- Being tested
- Imaging
- Keywords
- Attention, Deficit, Disorder, Hyperactivity, cerebellum, alteration, fronto-cerebello-frontal loops
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Disease, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingOther
neuropsychological evaluation and Imaging with magnetic resonance (MRI)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients with Attention Deficit Disorder with or without Hyperactivity Receives: Other: Imaging |
| 2 | Sham comparator | healthy volunteer without Attention Deficit Hyperactivity Disorder Receives: Other: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional anisotropy coefficient if fronto-cerebello-frontal loops.
Measured: visite 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2008
- Study completionJul 2008
Why it stopped: Difficulties in the organisation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Investigators
- Manuel BOUVARD, MD, Principal investigator, Charles Perrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684931
- Sponsor's protocol ID
- CHUBX 2007/21
- Acronym
- TDA/H
- Status last verified
- Jun 2009
- First submitted
- 22 May 2008
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT00684931
- Acronym / sponsor ID
- TDA/H / CHUBX 2007/21
- Keywords
- Attention, Deficit, Disorder, Hyperactivity, cerebellum, alteration, fronto-cerebello-frontal loops
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in the organisation
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Imagingpatients with Attention Deficit Disorder with or without Hyperactivity |
| 2 | Sham comparator | Other: Imaginghealthy volunteer without Attention Deficit Hyperactivity Disorder |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of ADHD
- 18 - 35 years old
- 18 - 35 years old
- no ADHD diagnosed
Key exclusion criteria (3 listed)
- Associated neurological or psychiatric pathologies
- Pregnant woman
- MRI counter indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagingneuropsychological evaluation and Imaging with magnetic resonance (MRI) | Other | 1, 2 |
Primary outcome
Fractional anisotropy coefficient if fronto-cerebello-frontal loops.
Time frame: visite 1
Results and safety
The study was stopped early (reason given: Difficulties in the organisation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel BOUVARD, MD principal investigator
Charles Perrens Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging in people with Attention Deficit Disorder With Hyperactivity, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in the organisation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy coefficient if fronto-cerebello-frontal loops. (time frame: visite 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2009.