Attention Deficit Hyperactivity Disorder (ADHD)NCT02578342
Brain Activity in Adults With ADHD During Neuropsychological Tasks
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
The aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to Nov 2020
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Three groups: 1. healthy volunteers 2. ADHD subjects receiving medications 3. medication-naive ADHD subjects
Who may be able to join
- Participant is between 20-55 years old
- Participant is not pregnant
Who cannot join
- Participant is not able to consent him/herself
- Suspected or proven pregnancy
- Nursing
- Neurological diseases that could interfere with a diagnosis of ADHD
- Psychiatric comorbidity under treatment
- Previous history of psychiatric medication
Show all 13Show fewer
- Substance abuse
- Intelligence quotient<75
- Claustrophobia
- Electrical simulator nerve or bone
- Implanted medication infusion pump
- Cerebral aneurysm clips
- Unstable medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Activity and Functional Connectivity in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) During Tasks of Motor Inhibition and Cognitive Switching
The aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD.
Read the detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most prevalent psychiatric disorders in children and adolescents. It is characterized by inattentive, hyperactive, impulsive behaviour and neuropsychological deficits. In 40-60% of cases emerge in childhood and persists into adulthood.
The aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD. As a secondary endpoint a more robust diagnosing method combining advanced imaging methods with neuropsychological evaluation is tested.
Neuropsychological testing, functional MRI and spectroscopy will be performed. Statistical analysis will assess differences in the functional magnetic resonance imaging, spectroscopy and neuropsychological evaluation results between three groups: 1) group of healthy volunteers, 2) participants with ADHD with medication and 3) participants with ADHD without medication.
- Being tested
- MRI
- 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.
MRIDevice
Functional Magnetic Resonance Imaging technique measures brain activity by detecting associated changes in blood oxygenation level dependency
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | healthy volunteer between age of 20 to 55 will undergo MRI examination. Receives: Device: MRI | |
| ADHD subjects without medication | Medication-naive subjects with ADHD (20-55 years) will undergo MRI examination. Receives: Device: MRI | |
| ADHD subjects with medication | Subjects with ADHD (20-55 years), under medication will undergo MRI examination. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood oxygenation level dependency (BOLD)
The study consist solely of one MRI examination performed within 2 hours.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Remonda, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578342
- Sponsor's protocol ID
- 1410.000.055
- Status last verified
- Apr 2022
- First submitted
- 3 Aug 2015
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berberat J, Huggenberger R, Montali M, Gruber P, Pircher A, Lovblad KO, Killer HE, Remonda L. Brain activation patterns in medicated versus medication-naive adults with attention-deficit hyperactivity disorder during fMRI tasks of motor inhibition and cognitive switching. BMC Med Imaging. 2021 Mar 19;21(1):53. doi: 10.1186/s12880-021-00579-3.
PubMed 33740903
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity and Functional Connectivity in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) During Tasks of Motor Inhibition and Cognitive Switching
- ClinicalTrials.gov ID
- NCT02578342
- Acronym / sponsor ID
- 1410.000.055
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 16 Oct 2015 (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 the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most prevalent psychiatric disorders in children and adolescents. It is characterized by inattentive, hyperactive, impulsive behaviour and neuropsychological deficits. In 40-60% of cases emerge in childhood and persists into adulthood.
The aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD. As a secondary endpoint a more robust diagnosing method combining advanced imaging methods with neuropsychological evaluation is tested.
Neuropsychological testing, functional MRI and spectroscopy will be performed. Statistical analysis will assess differences in the functional magnetic resonance imaging, spectroscopy and neuropsychological evaluation results between three groups: 1) group of healthy volunteers, 2) participants with ADHD with medication and 3) participants with ADHD without medication.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: MRIhealthy volunteer between age of 20 to 55 will undergo MRI examination. |
| ADHD subjects without medication | – | Device: MRIMedication-naive subjects with ADHD (20-55 years) will undergo MRI examination. |
| ADHD subjects with medication | – | Device: MRISubjects with ADHD (20-55 years), under medication will undergo MRI examination. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Three groups: 1. healthy volunteers 2. ADHD subjects receiving medications 3. medication-naive ADHD subjects
Key inclusion criteria (2 listed)
- Participant is between 20-55 years old
- Participant is not pregnant
Key exclusion criteria (13 listed)
- Participant is not able to consent him/herself
- Suspected or proven pregnancy
- Nursing
- Neurological diseases that could interfere with a diagnosis of ADHD
- Psychiatric comorbidity under treatment
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 |
|---|---|---|
| MRIFunctional Magnetic Resonance Imaging technique measures brain activity by detecting associated changes in blood oxygenation level dependency | Device | ADHD subjects with medication, ADHD subjects without medication, Healthy volunteers |
Primary outcome
Changes in blood oxygenation level dependency (BOLD)
Time frame: 2 hours
The study consist solely of one MRI examination performed within 2 hours.
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 7 Apr 2022.
- Derived from this study: PubMed 33740903Berberat J, Huggenberger R, Montali M, Gruber P, Pircher A, Lovblad KO, Killer HE, Remonda L. Brain activation patterns in medicated versus medication-naive adults with attention-deficit hyperactivity disorder during fMRI tasks of motor inhibition and cognitive switching. BMC Med Imaging. 2021 Mar 19;21(1):53. doi: 10.1186/s12880-021-00579-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (ADHD), run by Kantonsspital Aarau at 1 site in Switzerland.
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 2 inclusion and 13 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 7 Apr 2022. 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 Switzerland. 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?
Changes in blood oxygenation level dependency (BOLD) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02578342, which also lists 1 linked publication.
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 7 Apr 2022.