Attention Deficit Hyperactivity DisorderNCT02154321
Electroencephalogram and Attention Deficit Hyperactivity Disorder Study
An observational study of Attention Deficit Hyperactivity Disorder and Healthy Controls, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research is to assess and determine brain oscillations or "brain signatures" of adult participants with Attention Deficit Hyperactivity Disorder (ADHD) relative to adult participants without ADHD using the technique electroencephalogram (EEG). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Healthy Controls
- What is being tested?
- Electroencephalogram (EEG)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 15 Sep 2017
- 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
- Healthy volunteers accepted
- Adult
Study population: 100 adult participants will be recruited for this study: 50 adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls.
Who may be able to join
- Right-handedness
- Inclusion Criteria for Attention Deficit Hyperactivity Disorder (ADHD) group:
- Currently unmedicated adults with ADHD. To be given a full diagnosis of adult ADHD, the participant must have full Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R) criteria: (1) described a chronic course of ADHD symptomatology from childhood to adulthood, and (2) endorsed a moderate or sever level of impairment attributed to the ADHD symptoms.
Who cannot join
- Currently taking psychoative medications
- Any clinically significant neurological problem (e.g., tics, seizures, serious head injury)
- Alcohol or substance abuse (current or in the past 2 years)
- Any current Axis I psychiatric diagnosis (other than ADHD) as verified by clinical interview
Trial locations and contacts
1 site in 1 country.
United States1 site
Rachel Upjohn Building
Ann Arbor, Michigan, 48109-2700
About this study
Official title: EEG and ADHD Study
The purpose of this research is to assess and determine brain oscillations or "brain signatures" of adult participants with Attention Deficit Hyperactivity Disorder (ADHD) relative to adult participants without ADHD using the technique electroencephalogram (EEG). Electroencephalogram is entirely non-invasive way of tracking brain activity.The main goal of this study is to establish biological factors for determining the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD).
- Being tested
- Electroencephalogram (EEG)
- 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.
Electroencephalogram (EEG)Device
Also called ActiveTwo EEG System, Manufacturer: BioSemi, Supplier: Cortech Solutions, BEU Number: 409917
The electroencephalogram assesses brain electrical activity through surface recording disks (electrodes) which are placed near the participants' head using a custom designed Lycra cap. The electrodes transmit the signals which are then amplified and stored on a computer. The procedure is entirely non-invasive. Once an accurate signal is assured, the signal derived from the electrode cap is then amplified, transmitted to a computer, and stored for later analysis. Each participant will undergo the electroencephalogram (EEG) procedure only once for the duration of 30-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | This study aims to recruit 100 adult participants: 50 of which are adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls. All participants will perform a total of two tasks while connected to electroencephalogram (EEG) sensors; the first task is a resting state task and after that a cognitive challenge task (attention control). Study activity is performed in a single visit which lasts two hours. Participants will also be asked to complete some behavioral questionnaires. Receives: Device: Electroencephalogram (EEG) | |
| Healthy Control | This study aims to recruit 100 adult participants: 50 of which are adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls. All participants will perform a total of two tasks while connected to electroencephalogram (EEG) sensors; the first task is a resting state task and after that a cognitive challenge task (attention control). Study activity is performed in a single visit which lasts two hours. Participants will also be asked to complete some behavioral questionnaires. Receives: Device: Electroencephalogram (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Wave Measurements
Measurement of electroencephalogram amplitude and coherence in alpha, gamma, and theta brain wave bands.
Measured: Two years
Secondary outcomes (1)
Default Network Signatures
Measurement of the brain's default network consisting of interconnected midline and lateral parietal regions involved in internally directed mentation.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Why it stopped: Funding and resource restrictions.
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 University of MichiganThe 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandra Sekhar Sripada, University of Michigan
- Investigators
- Chandra S Sripada, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154321
- Sponsor's protocol ID
- HUM00081947
- Status last verified
- Nov 2017
- First submitted
- 30 May 2014
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG and ADHD Study
- ClinicalTrials.gov ID
- NCT02154321
- Acronym / sponsor ID
- HUM00081947
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding and resource restrictions.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 3 Jun 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.
The purpose of this research is to assess and determine brain oscillations or "brain signatures" of adult participants with Attention Deficit Hyperactivity Disorder (ADHD) relative to adult participants without ADHD using the technique electroencephalogram (EEG). Electroencephalogram is entirely non-invasive way of tracking brain activity.The main goal of this study is to establish biological factors for determining the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | – | Device: Electroencephalogram (EEG)This study aims to recruit 100 adult participants: 50 of which are adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls. All participants will perform a total of two tasks while connected to electroencephalogram (EEG) sensors; the first task is a resting state task and after that a cognitive challenge task (attention control). Study activity is performed in a single visit which lasts two hours. Participants will also be asked to complete some behavioral questionnaires. |
| Healthy Control | – | Device: Electroencephalogram (EEG)This study aims to recruit 100 adult participants: 50 of which are adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls. All participants will perform a total of two tasks while connected to electroencephalogram (EEG) sensors; the first task is a resting state task and after that a cognitive challenge task (attention control). Study activity is performed in a single visit which lasts two hours. Participants will also be asked to complete some behavioral questionnaires. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 adult participants will be recruited for this study: 50 adults diagnosed with Attention Deficit Hyperactivity Disorder and 50 healthy controls.
Key inclusion criteria (3 listed)
- Right-handedness
- Currently unmedicated adults with ADHD. To be given a full diagnosis of adult ADHD, the participant must have full Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R) criteria: (1) described a chronic course of ADHD symptomatology from childhood to adulthood, and (2) endorsed a moderate or sever level of impairment attributed to the ADHD symptoms.
Key exclusion criteria (4 listed)
- Currently taking psychoative medications
- Any clinically significant neurological problem (e.g., tics, seizures, serious head injury)
- Alcohol or substance abuse (current or in the past 2 years)
- Any current Axis I psychiatric diagnosis (other than ADHD) as verified by clinical interview
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 |
|---|---|---|
| Electroencephalogram (EEG)Also: ActiveTwo EEG System, Manufacturer: BioSemi, Supplier: Cortech Solutions, BEU Number: 409917The electroencephalogram assesses brain electrical activity through surface recording disks (electrodes) which are placed near the participants' head using a custom designed Lycra cap. The electrodes transmit the signals which are then amplified and stored on a computer. The procedure is entirely non-invasive. Once an accurate signal is assured, the signal derived from the electrode cap is then amplified, transmitted to a computer, and stored for later analysis. Each participant will undergo the electroencephalogram (EEG) procedure only once for the duration of 30-45 minutes. | Device | Attention Deficit Hyperactivity Disorder, Healthy Control |
Primary outcome
Brain Wave Measurements
Time frame: Two years
Measurement of electroencephalogram amplitude and coherence in alpha, gamma, and theta brain wave bands.
1 secondary outcome
Default Network Signatures
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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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.
Chandra S Sripada, MD, PhD principal investigator
University of Michigan
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 and Healthy Controls, run by University of Michigan at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 7 Nov 2017. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Brain Wave Measurements (time frame: Two years). 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 7 Nov 2017.