NCT03948607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

March 11, 2019

Last Update Submit

April 14, 2023

Conditions

Keywords

ElectroencephalographyNeurocognitionAttention deficitAttention lapses

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • CNV difference between missed and successful trials

    During EEG realized after the inclusion

  • CNV difference between missed and successful trials

    During EEG realized after the inclusion

  • Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering

    During EEG realized after the inclusion

  • Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering

    During EEG realized after the inclusion

  • Association between EEG lapses markers, neuropsychological measures of attention, clinical scales and subjective mindwandering

    During EEG realized after the inclusion

  • +3 more secondary outcomes

Study Arms (2)

Adult ADHD

Adult ADHD patients without current comorbidity and treatment.

Other: Electroencephalography during sustained attention task.

Healthy controls

Healthy controls without ADH, paired in age and gender.

Other: Electroencephalography during sustained attention task.

Interventions

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".

Also known as: CTET (Continuous Temporal Expectancy Task), SART (Sustained Attention to Response Task)
Adult ADHDHealthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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 ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Civil - service de Psychiatrie 2

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sébastien WEIBEL

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

May 14, 2019

Study Start

September 10, 2019

Primary Completion

May 5, 2021

Study Completion

May 5, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations