NCT04768556

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 5, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

3.7 years

First QC Date

February 5, 2021

Last Update Submit

May 8, 2024

Conditions

Attention DeficitHyperactivity Disorder

Keywords

KEYWORDS: Inhibitory controltime-frequency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Inhibition performance from a rhythmic-action task

    2 weeks

  • Inhibition performance from a discrete-action task

    2 weeks

Study Arms (3)

ADHD group

EXPERIMENTAL

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

Other: EEG experimental sessions 1Other: EEG experimental sessions 2

Control group 1

OTHER

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

Other: EEG experimental sessions 1Other: EEG experimental sessions 2

Control group 2

OTHER

Control group 2: 20 participants as healthy volunteers

Other: EEG experimental sessions 1Other: EEG experimental sessions 2

Interventions

EEG experimental sessions 1OTHER

An EEG experimentation session on the stop-signal task of inhibiting a prepared discrete graphic action.

ADHD groupControl group 1Control group 2
EEG experimental sessions 2OTHER

An EEG experimentation session on the stop-signal task of inhibiting an ongoing rhythmic action

ADHD groupControl group 1Control group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse Purpan University Hospital

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jeremie PARIENTE, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremie PARIENTE, MD PHD

CONTACT

05.61.77.95.02pariente.j@chu-toulouse.fr

Mario Hervaul, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 24, 2021

Study Start

March 17, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)