Attention-deficit/Hyperactivity DisorderNCT02720562
Addressing Motion and Confounds Issues in Resting fMRI- Application of Multi-echo EPI Scanning
An observational study of Attention-deficit/Hyperactivity Disorder, run by National Taiwan University Hospital.
Trial summary
Resting state functional MRI is widely used for studying brain functional networks. However, in-scanner head movement and other non-neuronal noise can disproportionately bias connectivity estimates, despite various preprocessing efforts. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: The sample consists of 40 adults with ADHD and 40 age-, sex-matched healthy volunteers.
Who may be able to join
- 1. Subjects who have clinical diagnosis of a ADHD according to the DSM-IV and DSM-5 diagnostic criteria
Who cannot join
- Systemic medical illness
- Current symptoms or lifetime history of DSM-5 diagnosis of mood disorder, any psychotic disorder, substance use disorder, learning disability, pervasive developmental disorder, claustrophobia, obsessive compulsive disorder, or mental retardation.
- With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy;
- Full-scale IQ < 80.
About this study
Resting state functional MRI is widely used for studying brain functional networks. However, in-scanner head movement and other non-neuronal noise can disproportionately bias connectivity estimates, despite various preprocessing efforts. To address these issues, the technique combining data acquisition with multiecho (ME) echo planar imaging and analysis with spatial independent component analysis (ICA), called ME-ICA, has been develop to distinguish BOLD (neuronal) and non-BOLD (artifactual) components based on linear echo-time dependence of signals, and has been demonstrated to successfully remove non-neuronal confounds. Nonetheless, such research approach has never been applied in psychiatric populations. The study aims to fill in the gap as shown in the following.
Read the detailed description
Specific Aims:
- To replicate feasibility and efficacy of multi-echo fMRI in removal of non-neuronal confounds as shown in work of Kundu and colleagues (2012, 2013)
- To characterize intrinsic functional connectivity(iFC) differences between adults with attention deficit hyperactivity disorder(ADHD) and healthy volunteers using ME-ICA denoising methods. Then compare the results with iFC differences derived from single-echo fMRI scan, in order to further separate "authentic" group differences from spurious findings introduced by non-neuronal confounds.
- To explore the neural signature of in-scanner motion restlessness by comparing intrasubject differences in iFC between single-echo and multi-echo fMRI, and inter-subject differences between subjects of high- and low- motion levels.
The investigators plan to recruit 80 participants (40 adults with ADHD, 40 healthy control), without current and past history of any systemic physical illness, neither any major psychiatric disorder other than ADHD. All the participants will receive psychiatric interviews (The Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia, K-SADS-E). They will receive the Wechsler Adult Intelligence Scale-3rd edition(WAIS-III) first to ensure their full-scale IQ greater than 80. The MRI assessments (T1 imaging, single-echo echo planar imaging(EPI) and multi-echo EPI resting-state fMRI) will be subsequently arranged within 2 weeks after psychiatric/neuropsychological assessments.
This study (1) will be the first report in Taiwan in terms of implementation of multi-echo EPI for denoise; (2) will be the first report in the world on the functional connective differences using multi-echo EPI; (3) will provide further evidence about the mechanism underpinning in-scanner motion restless and improve specificity of motion biomarkers by using multi-echo EPI.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- 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 | Subjects with clinical diagnosis of ADHD according to the DSM-IV criteria | |
| TD group | Typically development controls without lifetime diagnosis with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Interview
Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiang-Yuan Lin, MD, Principal investigator, Dept of Psychiatry, National Taiwan University HospitalSusan Shur-Fen Gau, MD, PhD, Study director, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720562
- Sponsor's protocol ID
- 201406032RINB
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2016
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Motion and Confounds Issues in Resting fMRI- Application of Multi-echo EPI Scanning
- ClinicalTrials.gov ID
- NCT02720562
- Acronym / sponsor ID
- 201406032RINB
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 28 Mar 2016 (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.
Resting state functional MRI is widely used for studying brain functional networks. However, in-scanner head movement and other non-neuronal noise can disproportionately bias connectivity estimates, despite various preprocessing efforts. To address these issues, the technique combining data acquisition with multiecho (ME) echo planar imaging and analysis with spatial independent component analysis (ICA), called ME-ICA, has been develop to distinguish BOLD (neuronal) and non-BOLD (artifactual) components based on linear echo-time dependence of signals, and has been demonstrated to successfully remove non-neuronal confounds. Nonetheless, such research approach has never been applied in psychiatric populations. The study aims to fill in the gap as shown in the following.
Detailed description
Specific Aims:
- To replicate feasibility and efficacy of multi-echo fMRI in removal of non-neuronal confounds as shown in work of Kundu and colleagues (2012, 2013)
- To characterize intrinsic functional connectivity(iFC) differences between adults with attention deficit hyperactivity disorder(ADHD) and healthy volunteers using ME-ICA denoising methods. Then compare the results with iFC differences derived from single-echo fMRI scan, in order to further separate "authentic" group differences from spurious findings introduced by non-neuronal confounds.
- To explore the neural signature of in-scanner motion restlessness by comparing intrasubject differences in iFC between single-echo and multi-echo fMRI, and inter-subject differences between subjects of high- and low- motion levels.
The investigators plan to recruit 80 participants (40 adults with ADHD, 40 healthy control), without current and past history of any systemic physical illness, neither any major psychiatric disorder other than ADHD. All the participants will receive psychiatric interviews (The Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia, K-SADS-E). They will receive the Wechsler Adult Intelligence Scale-3rd edition(WAIS-III) first to ensure their full-scale IQ greater than 80. The MRI assessments (T1 imaging, single-echo echo planar imaging(EPI) and multi-echo EPI resting-state fMRI) will be subsequently arranged within 2 weeks after psychiatric/neuropsychological assessments.
This study (1) will be the first report in Taiwan in terms of implementation of multi-echo EPI for denoise; (2) will be the first report in the world on the functional connective differences using multi-echo EPI; (3) will provide further evidence about the mechanism underpinning in-scanner motion restless and improve specificity of motion biomarkers by using multi-echo EPI.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | –Subjects with clinical diagnosis of ADHD according to the DSM-IV criteria |
| TD group | – | –Typically development controls without lifetime diagnosis with ADHD |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The sample consists of 40 adults with ADHD and 40 age-, sex-matched healthy volunteers.
Key inclusion criteria (1 listed)
- 1. Subjects who have clinical diagnosis of a ADHD according to the DSM-IV and DSM-5 diagnostic criteria
Key exclusion criteria (4 listed)
- Systemic medical illness
- Current symptoms or lifetime history of DSM-5 diagnosis of mood disorder, any psychotic disorder, substance use disorder, learning disability, pervasive developmental disorder, claustrophobia, obsessive compulsive disorder, or mental retardation.
- With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy;
- 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
Psychiatric Interview
Time frame: 1 hour
Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
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 28 Mar 2016.
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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.
Hsiang-Yuan Lin, MD principal investigator
Dept of Psychiatry, National Taiwan University Hospital
Susan Shur-Fen Gau, MD, PhD study director
National Taiwan University Hospital & College of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-deficit/Hyperactivity Disorder, run by National Taiwan University Hospital.
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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Psychiatric Interview (time frame: 1 hour). 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 28 Mar 2016.