MedTrace Logo

Added Value of the Oculomotor and Cognitive Examination in the Management of Patients With ADHD

NCT03411434 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-01-26

No results posted yet for this study

Summary

ADHD is a neurodevelopmental disorder characterized by symptoms of inattention and / or hyperactivity-impulsivity that affects nearly 6% of school-aged children and persists into adulthood. More and more studies are interested in biomarkers of this pathology. The oculomotricity, which allows to highlight deficits motor and attention present in ADHD, is used routinely in the expert centers. In general, the pharmacological treatment of ADHD is associated with a clinical response in approximately 70% of cases. Today, there is no review to predict the individual response to treatment.

Hypotheses The investigators hypothesize that a precise analysis of the oculomotor markers will allow to measure the improvement of the symptomatology of the ADHD disorder following the introduction of the psycho-stimulatory treatment. In other words, the investigators hypothesize that these markers could be a useful aid in patient follow-up by the clinician and allow early identification of responder and non-responder patients.

Primary objective The main objective of this study is to measure the added value of oculomotor examination in the follow-up of psycho-stimulant-treated ADHD patients.

Main Evaluation Criteria The primary endpoint is oculomotor performance. Parameters analyzed for each saccade are latency, amplitude, duration, average speed, direction.

Secondary Criteria Evaluation (s) Correlations will be established between oculomotor data and scores obtained at the clinical scales assessing ADHD symptoms of inattention and hyperactivity as well as cognitive performance. The data obtained before the introduction of the psycho-stimulant treatment (V0, baseline) will be compared with those obtained after acute administration of methylphenidate (10 mg orally,V1) and during the follow-up visit at 6 months (V2).

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Methylphenidate Oral Tablet

cf arm group description

Sponsors & Collaborators

  • Centre Hospitalier Rouffach

    lead OTHER

Principal Investigators

  • Fabrice Duval · Centre Hospitalier Rouffach

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-17
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411434 on ClinicalTrials.gov