Brain Structural ConnectivityNCT01677793
Developmental Trajectory of Brain Structural Connectivity and Cognitive Function From Childhood to Adulthood
An observational study of Brain Structural Connectivity and Cognitive Function, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Magnetic resonance imaging (MRI) is a premier modality to investigate structures and functions of human brain. In studies of children and adolescents, noninvasiveness of MRI makes it especially applicable. Developmental trajectory of gray matter volume and cortical thickness has been well studied in western countries. Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Structural Connectivity, Cognitive Function
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2012to 31 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 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The sample consists of 140 healthy volunteers (70 males and 70 females). The ranges of age are 8-21 (around 5 males and 5 females in each age group). They will be recruited from schools and colleges.
Who may be able to join
- Ages 8-21 without current and past history of any psychiatric disorder and autistic symptoms.
Who cannot join
- Current symptoms or lifetime history of DSM-IV-TR diagnosis of attention-deficit/hyperactivity disorder, pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, bipolar disorder, depression, severe anxiety disorders or substance use.
- With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy.
- With major systemic disease.
- Full-scale IQ < 80.
Trial locations and contacts
1 site in 1 country.
About this study
Magnetic resonance imaging (MRI) is a premier modality to investigate structures and functions of human brain. In studies of children and adolescents, noninvasiveness of MRI makes it especially applicable. Developmental trajectory of gray matter volume and cortical thickness has been well studied in western countries. However, significant variability of brain structure has been reported between Chinese and Caucasian, and the variation may also exist in developmental trajectory of the brain. However, the maturation processes of neural fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has been frequently used to investigate the integrity of fibertracts in the literature, is limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly developed technique to improve the resolution of crossing fibers, and it is more suitable for detailed tractography assessment. In addition to establishing the template of brain structure (T1 and T2) and structural connectivity of our child, adolescent, and young adult population, the study has the following three aims.
- To describe gender effect and developmental change of brain volume of different cortical and subcortical regions, thickness of cortex brain, and structural connectivity (e.g., frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and superior longitudinal fasciculus II) across childhood through adolescent to adulthood;
- To examine the gender effects and developmental change of attention, executive function and visual memory from childhood to adulthood and whether gender moderates these developmental changes; and
- To correlate the structural connectivity and brain size and neuropsychological function within the same subjects.
Read the detailed description
The investigators plan to recruit 140 healthy volunteers (70 males and 70 females), ages 8-21 without current and past history of any psychiatric disorder and autistic symptoms. All the participants will receive psychiatric interviews (K-SADS-E/SADS) and complete the Chinese AQ or SRS to screen for any psychiatric disorder or autistic symptoms. They will receive the WAIS-III or WISC-III (depending on their age) first to ensure their full-scale IQ greater than 80, followed by the CPT and CANTAB for a wide range assessments of attention, executive functions, and memory. The MRI assessments (T1 and T2 imaging, DSI, and resting-state fMRI) will be subsequently arranged within 2 weeks after psychiatric/neuropsychological assessments.
The investigators anticipate that this study (1) will establish the first template of brain anatomy and structural connectivity of children and adolescents in our population, (2) will be the first report on the developmental trajectory of brain of Chinese in both brain gross anatomy and tractography; (3) will provide evidence about how these development in brain structures associated with maturation in cognitive functions.
- Conditions
- Brain Structural Connectivity, Cognitive Function
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 |
|---|---|---|
| Child and adolescent population | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start1 Jan 2012
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Structural ConnectivityStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Statistical Center, NTUHCTC, National Taiwan University Hospital
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677793
- Sponsor's protocol ID
- 201105115RC
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2012
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chiang HL, Chen YJ, Shang CY, Tseng WY, Gau SS. Different neural substrates for executive functions in youths with ADHD: a diffusion spectrum imaging tractography study. Psychol Med. 2016 Apr;46(6):1225-38. doi: 10.1017/S0033291715002767. Epub 2016 Jan 8.
PubMed 26744120Chiang HL, Chen YJ, Lo YC, Tseng WY, Gau SS. Altered white matter tract property related to impaired focused attention, sustained attention, cognitive impulsivity and vigilance in attention-deficit/ hyperactivity disorder. J Psychiatry Neurosci. 2015 Sep;40(5):325-35. doi: 10.1503/jpn.140106.
PubMed 25871496
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Trajectory of Brain Structural Connectivity and Cognitive Function From Childhood to Adulthood
- ClinicalTrials.gov ID
- NCT01677793
- Acronym / sponsor ID
- 201105115RC
- Conditions
- Brain Structural Connectivity, Cognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 3 Sep 2012 (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.
Magnetic resonance imaging (MRI) is a premier modality to investigate structures and functions of human brain. In studies of children and adolescents, noninvasiveness of MRI makes it especially applicable. Developmental trajectory of gray matter volume and cortical thickness has been well studied in western countries. However, significant variability of brain structure has been reported between Chinese and Caucasian, and the variation may also exist in developmental trajectory of the brain. However, the maturation processes of neural fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has been frequently used to investigate the integrity of fibertracts in the literature, is limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly developed technique to improve the resolution of crossing fibers, and it is more suitable for detailed tractography assessment. In addition to establishing the template of brain structure (T1 and T2) and structural connectivity of our child, adolescent, and young adult population, the study has the following three aims.
- To describe gender effect and developmental change of brain volume of different cortical and subcortical regions, thickness of cortex brain, and structural connectivity (e.g., frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and superior longitudinal fasciculus II) across childhood through adolescent to adulthood;
- To examine the gender effects and developmental change of attention, executive function and visual memory from childhood to adulthood and whether gender moderates these developmental changes; and
- To correlate the structural connectivity and brain size and neuropsychological function within the same subjects.
Detailed description
The investigators plan to recruit 140 healthy volunteers (70 males and 70 females), ages 8-21 without current and past history of any psychiatric disorder and autistic symptoms. All the participants will receive psychiatric interviews (K-SADS-E/SADS) and complete the Chinese AQ or SRS to screen for any psychiatric disorder or autistic symptoms. They will receive the WAIS-III or WISC-III (depending on their age) first to ensure their full-scale IQ greater than 80, followed by the CPT and CANTAB for a wide range assessments of attention, executive functions, and memory. The MRI assessments (T1 and T2 imaging, DSI, and resting-state fMRI) will be subsequently arranged within 2 weeks after psychiatric/neuropsychological assessments.
The investigators anticipate that this study (1) will establish the first template of brain anatomy and structural connectivity of children and adolescents in our population, (2) will be the first report on the developmental trajectory of brain of Chinese in both brain gross anatomy and tractography; (3) will provide evidence about how these development in brain structures associated with maturation in cognitive functions.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child and adolescent population | – | – |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The sample consists of 140 healthy volunteers (70 males and 70 females). The ranges of age are 8-21 (around 5 males and 5 females in each age group). They will be recruited from schools and colleges.
Key inclusion criteria (1 listed)
- Ages 8-21 without current and past history of any psychiatric disorder and autistic symptoms.
Key exclusion criteria (4 listed)
- Current symptoms or lifetime history of DSM-IV-TR diagnosis of attention-deficit/hyperactivity disorder, pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, bipolar disorder, depression, severe anxiety disorders or substance use.
- With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy.
- With major systemic disease.
- Full-scale IQ < 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
Not reported in the source record.
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 2 Sep 2021.
- Derived from this study: PubMed 26744120Chiang HL, Chen YJ, Shang CY, Tseng WY, Gau SS. Different neural substrates for executive functions in youths with ADHD: a diffusion spectrum imaging tractography study. Psychol Med. 2016 Apr;46(6):1225-38. doi: 10.1017/S0033291715002767. Epub 2016 Jan 8.
- Derived from this study: PubMed 25871496Chiang HL, Chen YJ, Lo YC, Tseng WY, Gau SS. Altered white matter tract property related to impaired focused attention, sustained attention, cognitive impulsivity and vigilance in attention-deficit/ hyperactivity disorder. J Psychiatry Neurosci. 2015 Sep;40(5):325-35. doi: 10.1503/jpn.140106.
Related trials for Brain Structural Connectivity
Recruiting
Orchestra in Class, a Novel Booster for Executive Functions and Brain Development in Young Primary School Children
Development, Child, Executive Functions
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 Brain Structural Connectivity and Cognitive Function, 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 4 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 2 Sep 2021. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01677793, which also lists 2 linked publications.
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 2 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.