Neural Mechanisms of Attention Lapses in Adult ADHD

Attention Deficit Disorder Clinical Trial

— AttLapse-TDA  

Official title:

Neural Mechanisms Underlying Attention Lapses in Adult Attention Deficit Disorder: Towards a Better Clinical Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948607
• Other study ID #: 7248
• Status: Completed
• Start date: September 10, 2019
• Est. completion date: May 5, 2021

Study information

• Verified date: April 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ...)

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Disease
• Hyperactivity Disorder

Intervention

Other:
• Electroencephalography during sustained attention 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".

Locations

Country	Name	City	State
France	Hôpital Civil - service de Psychiatrie 2	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During EEG realized after the inclusion
Secondary	CNV difference between missed and successful trials	Time course analysis of electrophysiological markers (EEG) before an attention lapse : amplitude of the evoked potentials	During EEG realized after the inclusion
Secondary	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).	During EEG realized after the inclusion
Secondary	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)	During EEG realized after the inclusion
Secondary	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)	During EEG realized after the inclusion
Secondary	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)	During EEG realized after the inclusion
Secondary	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)	During EEG realized after the inclusion
Secondary	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	During EEG realized after the inclusion
Secondary	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	During EEG realized after the inclusion