Brain Activity Associated With Inhibition of Action in Attention-deficit (INHIB'MOV)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit; Hyperactivity Disorder
• Intervention / Treatment: Other: EEG experimental sessions 1; Other: EEG experimental sessions 2

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremie PARIENTE, MD PHD; Phone Number: 05.61.77.95.02; Email: pariente.j@chu-toulouse.fr
• Study Contact Backup: Name: Mario Hervaul, MS

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • Toulouse Purpan University Hospital
    • Contact: Jeremie PARIENTE, MD PHD; Phone Number: 0561779502; Email: pariente.j@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD group; ADHD group: 20 participants having received a positive diagnosis of ADHD	Other: EEG experimental sessions 1; An EEG experimentation session on the stop-signal task of inhibiting a prepared discrete graphic action.; Other: EEG experimental sessions 2; An EEG experimentation session on the stop-signal task of inhibiting an ongoing rhythmic action
Other: Control group 1; Control group 1: 20 participants having received a negative diagnosis of ADHD	Other: EEG experimental sessions 1; An EEG experimentation session on the stop-signal task of inhibiting a prepared discrete graphic action.; Other: EEG experimental sessions 2; An EEG experimentation session on the stop-signal task of inhibiting an ongoing rhythmic action
Other: Control group 2; Control group 2: 20 participants as healthy volunteers	Other: EEG experimental sessions 1; An EEG experimentation session on the stop-signal task of inhibiting a prepared discrete graphic action.; Other: EEG experimental sessions 2; An EEG experimentation session on the stop-signal task of inhibiting an ongoing rhythmic action

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG correlates of inhibition	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhibition performance from a rhythmic-action task	The inhibition performance from a rhythmic-action task, expressed as stop-signal reaction time (SSRT, in ms). This latency is measured by identifying a statistical deviation evoked by the STOP signal in the participants' movement on a graphic tablet (following the procedure described in Hervault et al., 2019).	2 weeks
Inhibition performance from a discrete-action task	The inhibition performance from a discrete-action task, expressed as an SSRT (in ms). According to the horse-race model of inhibition, this latency is estimated based on the response time and the response probability obtained by the participants when responding to the GO and STOP stimuli used in the task (following recent guidelines from Verbruggen et al., 2019).	2 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Centre National de la Recherche Scientifique, France
• Investigators: Principal Investigator: Jérémie PARIENTE, MD PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: KEYWORDS: Inhibitory control; time-frequency
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: RC31 /20/0252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No