Clinical trial NCT03948607: Neural Mechanisms of Attention Lapses in Adult ADHD
Official title: Neural Mechanisms Underlying Attention Lapses in Adult Attention Deficit Disorder: Towards a Better Clinical Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder
Hyperactivity Disorder
Keywords: Electroencephalography
Neurocognition
Attention deficit
Attention lapses
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* 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 ...)

Primary outcomes:
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).
timeFrame: During EEG realized after the inclusion
Secondary outcomes:
measure: CNV difference between missed and successful trials
timeFrame: During EEG realized after the inclusion
measure: CNV difference between missed and successful trials
timeFrame: During EEG realized after the inclusion
measure: Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
timeFrame: During EEG realized after the inclusion
measure: Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
timeFrame: During EEG realized after the inclusion
measure: Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
timeFrame: During EEG realized after the inclusion
measure: Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering
timeFrame: During EEG realized after the inclusion
measure: EEG lapse markers according attentional subjective state
timeFrame: During EEG realized after the inclusion
measure: EEG lapse markers according attentional subjective state
timeFrame: During EEG realized after the inclusion
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpital Civil - service de Psychiatrie 2
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Sébastien WEIBEL
role: PRINCIPAL_INVESTIGATOR
References: