Attention Deficit Hyperactivity DisorderNCT02232464
Disturbed Structural Connectivity of Frontostriatal and Frontoparietal Networks in Adults With ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive deficits may last to adulthood. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The sample consists of 50 adults (ages 18-45) with clinical diagnosis of ADHD according to the DSM-IV criteria and 50 age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD.
Who may be able to join
- Subjects aged 18-45, who have clinical diagnosis of a ADHD according to the DSM-IV criteria.
Who cannot join
- The subjects will be excluded from the study if they meet any of the following criteria: (1) Comorbidity with diagnoses of autism spectrum disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; (3)With visual or hearing impairments, or motor disability which may influence the process of MRI assessment; and (4) Full-scale IQ lower than 80.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disturbed Structural Connectivity of Frontostriatal and Frontoparietal Networks in Adults With Attention-deficit Hyperactivity Disorder
Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive deficits may last to adulthood. Our previous studies, like western results, have shown that children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways and impaired brain activity in frontoparietal network. However, there is lack of data with regards to whether adults with ADHD also demonstrate structural and functional disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls without ADHD in Asian population and no study has been done to correlate a wide range of executive functions with the connectivity of these two networks.
Specific Aims:
- to compare the executive functions, and structural and functional connectivity in frontostriatal and frontoparietal circuitries between adults with ADHD and healthy controls without ADHD;
- to correlate the data from structural and functional connectivity, executive functions, and ADHD core symptoms stratifying by the ADHD and controls; and
- to explore other circuitries that may involve in ADHD by using whole brain tractography analyses.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Adult ADHD, diffusion spectrum imaging, resting-state fMRI, frontostriatal circuitries, frontoparietal circuitries, executive function
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Adults with clinical diagnosis of ADHD according to the DSM-IV criteria | |
| Control group | Age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural neuroimaging
Using diffusing spectrum imaging (DSI) to assess the structural connectivity in frontostriatal, frontoparietal and other circuitries.
Measured: one day
Secondary outcomes (1)
Functional connectivity of the brain circuits
Using resting-state functional MRI (rsfMRI) to assess the functional connectivity in frontostriatal, frontoparietal and other circuitries.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232464
- Sponsor's protocol ID
- 201312144RINB
- Status last verified
- Mar 2015
- First submitted
- 27 Aug 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disturbed Structural Connectivity of Frontostriatal and Frontoparietal Networks in Adults With Attention-deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02232464
- Acronym / sponsor ID
- 201312144RINB
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Adult ADHD, diffusion spectrum imaging, resting-state fMRI, frontostriatal circuitries, frontoparietal circuitries, executive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Sep 2014 (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.
Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive deficits may last to adulthood. Our previous studies, like western results, have shown that children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways and impaired brain activity in frontoparietal network. However, there is lack of data with regards to whether adults with ADHD also demonstrate structural and functional disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls without ADHD in Asian population and no study has been done to correlate a wide range of executive functions with the connectivity of these two networks.
Specific Aims:
- to compare the executive functions, and structural and functional connectivity in frontostriatal and frontoparietal circuitries between adults with ADHD and healthy controls without ADHD;
- to correlate the data from structural and functional connectivity, executive functions, and ADHD core symptoms stratifying by the ADHD and controls; and
- to explore other circuitries that may involve in ADHD by using whole brain tractography analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | –Adults with clinical diagnosis of ADHD according to the DSM-IV criteria |
| Control group | – | –Age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample consists of 50 adults (ages 18-45) with clinical diagnosis of ADHD according to the DSM-IV criteria and 50 age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD.
Key inclusion criteria (1 listed)
- Subjects aged 18-45, who have clinical diagnosis of a ADHD according to the DSM-IV criteria.
Key exclusion criteria (1 listed)
- The subjects will be excluded from the study if they meet any of the following criteria: (1) Comorbidity with diagnoses of autism spectrum disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; (3)With visual or hearing impairments, or motor disability which may influence the process of MRI assessment; and (4) Full-scale IQ lower than 80.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Structural neuroimaging
Time frame: one day
Using diffusing spectrum imaging (DSI) to assess the structural connectivity in frontostriatal, frontoparietal and other circuitries.
1 secondary outcome
Functional connectivity of the brain circuits
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Susan Shur-Fen Gau, MD, PhD principal investigator
National Taiwan University Hospital & College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Structural neuroimaging (time frame: one day). 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 18 Mar 2015.