Attention Deficit DisorderAttLapse-TDANCT03948607
Neural Mechanisms of Attention Lapses in Adult ADHD
An observational study of Attention Deficit Disorder and Hyperactivity Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
ADHD is a common disorder, leading to a significant disability that often persists in adulthood. ADHD is characterized by attentional disturbances that are difficult to asses with standard neuropsychological tests. Attention tends to stall after a certain time of fatigue (i.e. an attention lapse). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder, Hyperactivity Disorder
- What is being tested?
- Electroencephalography during sustained attention task.
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2019to 5 May 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients included in the ADHD group are patients assessed during a specialized consultation on adult ADHD This consultation corresponds to standard care, during which a clinical examination is performed, as well as an interview with the psychiatrist. If the diagnosis of ADHD is confirmed, comorbidities are systematically sought and the eligibility criteria for inclusion of the patient in the study are verified. Healthy control are recruited by advertising.
Who may be able to join
- Diagnosis of ADHD according to DSM-5 criteria by a psychiatrist with clinical experience with ADHD
- aged 18 to 60
- having signed an informed consent
- able to understand the objectives and the risks related to the research
- For Healthy controls
- Absence of psychiatric disorder or neurological disease
- Matched in sex, age (± 2 years) and level of study (± 2 years) to each ADHD patient
Who cannot join
- treatment by Methylphenidate or amphetamine in the 3 months preceding the study
- treatment by a psychotropic drug other than antidepressant SSRI: anti-depressant non-SSRI, antipsychotic, mood stabilizer, benzodiazepine or hypnotic daily intake
- neurological pathology or neurological sequelae
- history of head trauma with loss of consciousness of more than 15 minutes
- Subject under the protection of justice
- Subject under guardianship, curatorship
- Subject in exclusion period (determined by previous or current study),
- Impossibility to give the subject enlightened information (subject in emergency situation, difficulties of comprehension of the subject (for example mental retardation, illiteracy, subject not including French ...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Mechanisms Underlying Attention Lapses in Adult Attention Deficit Disorder: Towards a Better Clinical Diagnosis
ADHD is a common disorder, leading to a significant disability that often persists in adulthood. ADHD is characterized by attentional disturbances that are difficult to asses with standard neuropsychological tests.
Attention tends to stall after a certain time of fatigue (i.e. an attention lapse). The aim of this study is to study the electroencephalographic (EEG) characteristics of these attention lapses in a sustained attention task, comparing ADHD patients with healthy subjects.
Read the detailed description
The main goal is to assess with EEG the timing of the attentional demobilization that precedes a sustained attention lapse in patients with ADHD.
The secondary objectives are: 1 / To analyze impaired cognitive control mechanisms during lapses in patients with ADHD; 2 / Study the relationships between the deficits identified through EEG recording, clinical evaluations, and the subjective perception of daily difficulties; 3 / To measure the impact of the subjective attention state on the neuronal precursors of the attentional lapses; 4 / Evaluate the relation between propensity to wandering mind and attentional lapses.
- Conditions
- Attention Deficit Disorder, Hyperactivity Disorder
- Being tested
- Electroencephalography during sustained attention task.
- Keywords
- Electroencephalography, Neurocognition, Attention deficit, Attention lapses
- 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.
Electroencephalography during sustained attention task.Other
Also called CTET (Continuous Temporal Expectancy Task), SART (Sustained Attention to Response Task)
The Continuous Temporal Expectancy Task (CTET) (O'Connell et al., 2009) is a very demanding discrimination task with sustained attention. It consists of the presentation on a computer screen of a visual pattern resembling a checkerboard that changes orientation at regular intervals of time. In this task the subject must respond (pressing a response button) to the appearance of rare target stimuli that have a longer duration (1120 ms) than non-target stimuli (800 ms).
SART (Sustained Attention to Response Task) (Robertson et al., 1997) is a task of inhibition (Go / No-Go task) to evaluate the capacities of sustained attention. It consists in the successive and random presentation on a computer screen of the numbers from 1 to 9. In this task the subject must respond, by pressing a response button, to the appearance of all the numbers (very non-target stimuli frequent), with the exception of the number "3".
| Study group | Role | What they receive |
|---|---|---|
| Adult ADHD | Adult ADHD patients without current comorbidity and treatment. Receives: Other: Electroencephalography during sustained attention task. | |
| Healthy controls | Healthy controls without ADH, paired in age and gender. Receives: Other: Electroencephalography during sustained attention task. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral amplitude of the alpha band (8-14 Hz) to the quantitative EEG during the period up to 20 seconds before the successful trials vs. missed trials (lapse).
In healthy subjects, EEG changes, including increased parieto-occipital activity in the alphas frequency band (8-14Hz), have been observed 20 seconds before lapse (O'Connell et al., 2009). The analysis of the evoked potentials associated with the stimuli presented just before the occurrence of the target stimulus, reveals that the amplitude of the P300 on the 5 trials preceding the target to be detected is significantly lower before an omission (lapse) than before a correct detection.
Measured: During EEG realized after the inclusion
Secondary outcomes (8)
CNV difference between missed and successful trials
Time course analysis of electrophysiological markers (EEG) before an attention lapse : amplitude of the evoked potentials
Measured: During EEG realized after the inclusion
CNV difference between missed and successful trials
Time course analysis of electrophysiological markers (EEG) after a successful test: amplitude of the evoked potentials and theta power (intensity in μV).
Measured: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Regression and correlation analyzes involving electrophysiological markers associated with attentional lapses (see main objective)
Measured: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Regression and correlation analyzes involving electrophysiological markers associated with neuropsychological attention test scores (TAP)
Measured: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Regression and correlation analyzes involving electrophysiological markers associated with clinical scales (self-report ASRS and WFIRS)
Measured: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Regression and correlation analyzes involving electrophysiological markers associated with subjective measures of mind wandering (ad hoc questionnaire)
Measured: During EEG realized after the inclusion
EEG lapse markers according attentional subjective state
Frequency of lapses of attentional lapses (evoked potentials P3a and CNV, theta power) (intensity in μV), according to the attentional state described by the subjects during the evaluations during the task
Measured: During EEG realized after the inclusion
EEG lapse markers according attentional subjective state
amplitude electrophysiological markers (EEG) of attentional lapses (evoked potentials P3a and CNV, theta power) (intensity in μV), according to the attentional state described by the subjects during the evaluations during the task
Measured: During EEG realized after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start10 Sep 2019
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien WEIBEL, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948607
- Sponsor's protocol ID
- 7248
- Acronym
- AttLapse-TDA
- Status last verified
- Apr 2023
- First submitted
- 11 Mar 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Underlying Attention Lapses in Adult Attention Deficit Disorder: Towards a Better Clinical Diagnosis
- ClinicalTrials.gov ID
- NCT03948607
- Acronym / sponsor ID
- AttLapse-TDA / 7248
- Conditions
- Attention Deficit Disorder, Hyperactivity Disorder
- Keywords
- Electroencephalography, Neurocognition, Attention deficit, Attention lapses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 14 May 2019 (actual)
- 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.
ADHD is a common disorder, leading to a significant disability that often persists in adulthood. ADHD is characterized by attentional disturbances that are difficult to asses with standard neuropsychological tests.
Attention tends to stall after a certain time of fatigue (i.e. an attention lapse). The aim of this study is to study the electroencephalographic (EEG) characteristics of these attention lapses in a sustained attention task, comparing ADHD patients with healthy subjects.
Detailed description
The main goal is to assess with EEG the timing of the attentional demobilization that precedes a sustained attention lapse in patients with ADHD.
The secondary objectives are: 1 / To analyze impaired cognitive control mechanisms during lapses in patients with ADHD; 2 / Study the relationships between the deficits identified through EEG recording, clinical evaluations, and the subjective perception of daily difficulties; 3 / To measure the impact of the subjective attention state on the neuronal precursors of the attentional lapses; 4 / Evaluate the relation between propensity to wandering mind and attentional lapses.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult ADHD | – | Other: Electroencephalography during sustained attention task.Adult ADHD patients without current comorbidity and treatment. |
| Healthy controls | – | Other: Electroencephalography during sustained attention task.Healthy controls without ADH, paired in age and gender. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients included in the ADHD group are patients assessed during a specialized consultation on adult ADHD This consultation corresponds to standard care, during which a clinical examination is performed, as well as an interview with the psychiatrist. If the diagnosis of ADHD is confirmed, comorbidities are systematically sought and the eligibility criteria for inclusion of the patient in the study are verified. Healthy control are recruited by advertising.
Key inclusion criteria (7 listed)
- Diagnosis of ADHD according to DSM-5 criteria by a psychiatrist with clinical experience with ADHD
- aged 18 to 60
- having signed an informed consent
- able to understand the objectives and the risks related to the research
- For Healthy controls
Key exclusion criteria (8 listed)
- treatment by Methylphenidate or amphetamine in the 3 months preceding the study
- treatment by a psychotropic drug other than antidepressant SSRI: anti-depressant non-SSRI, antipsychotic, mood stabilizer, benzodiazepine or hypnotic daily intake
- neurological pathology or neurological sequelae
- history of head trauma with loss of consciousness of more than 15 minutes
- Subject under the protection of justice
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 |
|---|---|---|
| Electroencephalography during sustained attention task.Also: CTET (Continuous Temporal Expectancy Task), SART (Sustained Attention to Response Task)The Continuous Temporal Expectancy Task (CTET) (O'Connell et al., 2009) is a very demanding discrimination task with sustained attention. It consists of the presentation on a computer screen of a visual pattern resembling a checkerboard that changes orientation at regular intervals of time. In this task the subject must respond (pressing a response button) to the appearance of rare target stimuli that have a longer duration (1120 ms) than non-target stimuli (800 ms). SART (Sustained Attention to Response Task) (Robertson et al., 1997) is a task of inhibition (Go / No-Go task) to evaluate the capacities of sustained attention. It consists in the successive and random presentation on a computer screen of the numbers from 1 to 9. In this task the subject must respond, by pressing a response button, to the appearance of all the numbers (very non-target stimuli frequent), with the exception of the number "3". | Other | Adult ADHD, Healthy controls |
Primary outcome
Spectral amplitude of the alpha band (8-14 Hz) to the quantitative EEG during the period up to 20 seconds before the successful trials vs. missed trials (lapse).
Time frame: During EEG realized after the inclusion
In healthy subjects, EEG changes, including increased parieto-occipital activity in the alphas frequency band (8-14Hz), have been observed 20 seconds before lapse (O'Connell et al., 2009). The analysis of the evoked potentials associated with the stimuli presented just before the occurrence of the target stimulus, reveals that the amplitude of the P300 on the 5 trials preceding the target to be detected is significantly lower before an omission (lapse) than before a correct detection.
8 secondary outcomes
CNV difference between missed and successful trials
Time frame: During EEG realized after the inclusion
CNV difference between missed and successful trials
Time frame: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Time frame: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Time frame: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Time frame: During EEG realized after the inclusion
Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
Time frame: During EEG realized after the inclusion
EEG lapse markers according attentional subjective state
Time frame: During EEG realized after the inclusion
EEG lapse markers according attentional subjective state
Time frame: During EEG realized after the inclusion
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 18 Apr 2023.
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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.
Sébastien WEIBEL principal investigator
Hôpitaux Universitaires de Strasbourg
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 Disorder and Hyperactivity Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
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 7 inclusion and 8 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 18 Apr 2023. 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 France. 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?
Spectral amplitude of the alpha band (8-14 Hz) to the quantitative EEG during the period up to 20 seconds before the successful trials vs. missed trials (lapse). (time frame: During EEG realized after the inclusion). 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 18 Apr 2023.