A Longitudinal Follow-up Study of Neuroimage and Neuropsychological Endophenotype Study on ADHD

NCT03679403 | Completed DMC

• 1 other identifier: 201701033RIND
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 1

Brief Summary

Attention deficit/hyperactivity disorder (ADHD) is a common (3-10%), early-onset, clinically and genetically heterogeneous neuropsychiatric disorder with lifelong neuropsychological deficits. Despite many imaging studies on ADHD across countries, only few longitudinal studies investigated the developmental changes of structural and functional brain connectivity and some imaging studies using unaffected sibling design in western countries. There is no published data regarding developmental changes in brain functions assessed by neuropsychology/physiology/image in Asia and Taiwan as well. The ultimate goals of this 3-year project are to identify which neuropsychological, functional and structural connectivity, and neurophysiological variables can be effective endophenotypes (biomarkers) for ADHD based on this follow-up unaffected sibling study design. Due to the limitation of diffusion tensor image (DTI), original analysis of diffusion spectrum image (DSI), and single-echo resting-state functional MRI (SE rsfMRI), the investigators will adopt Mean Apparent Propagator (MAP)-MRI, tract-based autonomic analysis (TBAA) and multi-echo (ME) rsfMRI in this project. With the accomplishment of the following study goals, this study will be the first longitudinal follow-up neuroimaging/physiological endophenotypes study on ADHD using advanced imaging techniques and comprehensive clinical and neurocognitive data.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (5)

• Neuropsychological functions: Continuous Performance Test(CPT)

  The 4 dimensions of CCPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance.

  1 day

• Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)

  The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making.

  1 day

• Structural neuroimaging: Diffusing spectrum imaging (DSI)

  Using a pulsed-gradient spin-echo diffusion EPI(echo planar imaging) sequence with a twice-refocused balanced echo to acquire diffusion-weighted images

  1 day

• Functional connectivity: Single-echo (SE)

  SE will be used to evaluate functional connectivity.

  1 day

• Multi-echo (ME) Resting-state fMRI (rsfMRI)

  rsfMRI will be used to evaluate functional connectivity.

  1 day

Study Arms (3)

ADHD Probands

Subjects with DSM-IV ADHD who received the same MRI and CANTAB+CPT assessments during 2010.8-2015.7(NCT00916851, NCT01682915) at their age of 8-17 will be reassessed at the estimated age of 15-25.

Other: Psychiatric diagnosis

Unaffected siblings of ADHD

The unaffected siblings received the MRI and CANTAB+CPT assessments during 2013.8-2015.7 (NCT01682915) will be recruited and assessed.

Other: Psychiatric diagnosis

Neurotypicals Follow-up

Subjects without any lifetime diagnosis of DSM-IV ADHD or other psychiatric disorders as the control group of the ADHDFU group around 4-8 years ago when they received the same MRI and neuropsychological assessments during 2010.8-2015.7(NCT00916851, NCT01682915) at their age of 8-17 will be reassessed at their estimated age of 15-25.

Other: Psychiatric diagnosis

Interventions

Psychiatric diagnosis OTHER

Kiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5

ADHD Probands; Neurotypicals Follow-up; Unaffected siblings of ADHD

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This 3-year follow-up study will repeat the same neuropsychological (CANTAB, CPT) and MRI (T1, T2, DSI, SE- rsfMRI, counting stroop fMRI) assessments at Time 1 and additionally assess electrophysiology (MMN, Gamma ASSR), fMRI (ME rsfMRI, tasks fMRI) and Computerized Neuropsychological Battery (CNB) among 138 probands with ADHD, 61 unaffected siblings, and 135 neurotypicals who had the same neuropsychological and imaging assessments in 2010.8-2015.7(NCT00916851, NCT01682915).

You may qualify if:

• Subjects who received the same MRI and neuropsychological assessments during 2010.8-2015.7(NCT00916851, NCT01682915).

You may not qualify if:

• Subjects will be excluded from the study if they have (1) neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, or history of craniotomy; and (2) visual or hearing impairments, or motor disability which may influence MRI assessment.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 20, 2018
• Study Start: August 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

TW (1)