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Clinical Trials/NCT04768556
NCT04768556
Recruiting
Not Applicable

Assessment of Brain Activity Associated With Inhibition of Action in Attention-deficit Hyperactivity Disorder

University Hospital, Toulouse1 site in 1 country60 target enrollmentMarch 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit
Sponsor
University Hospital, Toulouse
Enrollment
60
Locations
1
Primary Endpoint
EEG correlates of inhibition
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Inhibitory control allows individuals to suppress unwanted actions and to resist irrelevant stimuli. It is thought to be a core deficit in Attention-deficit/hyperactivity disorder (ADHD). The present study aims at evaluating this deficit in adults with ADHD. Executive and inhibitory capacities, as well as the neural mechanisms underlying inhibitory control, will be assessed in adults with ADHD and two control groups of participants.

Detailed Description

ADHD is a psychiatric disorder characterized by symptoms of inattention, hyperactivity, and impulsivity (DSM-V, 2013). An impairment of inhibitory control has been suggested as the primary deficit in children with ADHD, which is thought to cause secondary impairments in executive functioning. A few studies investigated executive capacities in adults with ADHD. Specifically, an impairment in action inhibition has been reported in ADHD participants. Moreover, inhibition of action is often associated with distinctive electroencephalographic (EEG) correlates. The present study aim at combining both novel inhibitory control measurement techniques and EEG analysis in temporal and frequency domains to assess the sensitivity and the specificity of an inhibitory deficit in adults with ADHD. This is part of an improvement in the procedures for diagnosing ADHD syndrome and its functional evaluation. The study will analyze the EEG activity associated with two stop-signal tasks requiring inhibitory capacities. A set of other cognitive skills will also be evaluated during a neuropsychological assessment. The results of ADHD patients will be compared with those of a control group (healthy volunteers) to assess the sensitivity of an inhibition deficit to the disorder. These same results will also be compared with those of a second control group (patients with a negative diagnosis of ADHD) to assess the specificity of the inhibitory deficit. This experimental strategy results in the involvement of three groups of participants (ADHD patients and two control groups) in three visits (neuropsychological assessment and two EEG sessions).

Registry
clinicaltrials.gov
Start Date
March 17, 2021
End Date
December 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 18 and 50,
  • Visual, auditory (authorized apparatus), motor skills suitable for the proper realization of neuropsychological tests,
  • Being right-handed,
  • Free, informed and written consent signed by the participant and the investigator
  • Person affiliated or beneficiary of a social security scheme.
  • For the ADHD group:
  • Diagnosis of ADHD according to DSM-V criteria (APA, 2013),
  • For the patient control group:
  • Patient who consulted for a cognitive complaint and for whom the diagnosis of ADHD was rejected according to the criteria of DSM-V (APA, 2013).

Exclusion Criteria

  • General or progressive neurological disease resulting in cognitive impairment (multiple sclerosis, Parkinson's disease, stroke, etc.),
  • Insufficient linguistic level in French to participate in neuropsychological assessment,
  • Patient placed under judicial protection or under another protective regime,
  • Severe depression according to DSM-V criteria (APA, 2013),
  • Autism spectrum disorder, developmental coordination disorder.
  • For the healthy voluntary control group:
  • Presence of a cognitive complaint or pathology which may impair his cognitive functions

Outcomes

Primary Outcomes

EEG correlates of inhibition

Time Frame: 2 weeks

The main objective of this study is to evaluate, by electrophysiological measures, the presence of a deficit of action inhibition in adults with ADHD. To this end, the EEG correlates of inhibition will be compared between participants in the three groups. Thus, the ERP (N2 / P3) and ERSP (Theta, Delta) variations observed in terms of amplitude and latency in the stop-signal task tests will be computed in each of the three groups.

Secondary Outcomes

  • Inhibition performance from a rhythmic-action task(2 weeks)
  • Inhibition performance from a discrete-action task(2 weeks)

Study Sites (1)

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