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

Primary Purpose

Attention Deficit, Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EEG experimental sessions 1
EEG experimental sessions 2
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit focused on measuring KEYWORDS: Inhibitory control, time-frequency

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Toulouse Purpan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

ADHD group

Control group 1

Control group 2

Arm Description

ADHD group: 20 participants having received a positive diagnosis of ADHD

Control group 1: 20 participants having received a negative diagnosis of ADHD

Control group 2: 20 participants as healthy volunteers

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
February 5, 2021
Last Updated
June 19, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT04768556
Brief Title
Brain Activity Associated With Inhibition of Action in Attention-deficit
Acronym
INHIB'MOV
Official Title
Assessment of Brain Activity Associated With Inhibition of Action in Attention-deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit, Hyperactivity Disorder
Keywords
KEYWORDS: Inhibitory control, time-frequency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is pathophysiological, monocentric, comparative, and controlled with 3 groups compared: ADHD patients, control patients (negative diagnosis of ADHD), and healthy volunteers. The three groups will complete the same protocol, in the same manner.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADHD group
Arm Type
Experimental
Arm Description
ADHD group: 20 participants having received a positive diagnosis of ADHD
Arm Title
Control group 1
Arm Type
Other
Arm Description
Control group 1: 20 participants having received a negative diagnosis of ADHD
Arm Title
Control group 2
Arm Type
Other
Arm Description
Control group 2: 20 participants as healthy volunteers
Intervention Type
Other
Intervention Name(s)
EEG experimental sessions 1
Intervention Description
An EEG experimentation session on the stop-signal task of inhibiting a prepared discrete graphic action.
Intervention Type
Other
Intervention Name(s)
EEG experimental sessions 2
Intervention Description
An EEG experimentation session on the stop-signal task of inhibiting an ongoing rhythmic action
Primary Outcome Measure Information:
Title
EEG correlates of inhibition
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Inhibition performance from a rhythmic-action task
Description
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).
Time Frame
2 weeks
Title
Inhibition performance from a discrete-action task
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremie PARIENTE, MD PHD
Phone
05.61.77.95.02
Email
pariente.j@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Hervaul, MS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremie PARIENTE, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse Purpan University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremie PARIENTE, MD PHD
Phone
0561779502
Email
pariente.j@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Brain Activity Associated With Inhibition of Action in Attention-deficit

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