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

NCT03411434 | Unknown

• 1 other identifier: AO-005/20131104
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oculomotor performances; neurocognition; methylphenidate

Outcome Measures

Primary Outcomes (6)

• Change in saccade latency after acute and chronic 6-month administration of methylphenidate vs. baseline

  Latency (time between the onset of the target and the beginning of the eye movements in milliseconds)

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

• Change in saccade average speed after acute and chronic 6-month administration of methylphenidate vs. baseline

  Average speed of the saccade (degree per second)

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

• Change in saccade accuracy after acute and chronic 6-month administration of methylphenidate vs. baseline

  Saccade accuracy (characterized by the ratio of the amplitude of the first saccade to the amplitude of the target, expressed in percentage)

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

• Change in direction errors after acute and chronic 6-month administration of methylphenidate vs. baseline

  Direction errors (in percentage)

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

• Change in anticipatory saccades after acute and chronic 6-month administration of methylphenidate vs. baseline

  Anticipatory saccades (saccade initiated \< 80 msec after target appearance, in percentage)

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

• Change in express saccades after acute and chronic 6-month administration of methylphenidate vs. baseline

  Express saccades (reaction time between 80 and 130 msec, expressed in percentage).

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

Secondary Outcomes (2)

• Associations between clinical outcome after 6 month's methylphenidate treatment and change in oculomotor performance (from V0 to V1, V0 to V2, and V1 to V2)

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

• Associations between oculomotor data and neurocognitive test results

  Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)

Study Arms (1)

ADHD patients

EXPERIMENTAL

90 patients will be enrolled and assessed (i.e., neurocognitive and oculomotor tests) at baseline ; after a single low dose of methylphenidate (10 mg orally); and after 6 months of adequate dose of methylphenidate oral tablet

Drug: Methylphenidate Oral Tablet

Interventions

Methylphenidate Oral Tablet DRUG

cf arm group description

Also known as: oculometry (eye tracking), neurocognition (TAP battery)

ADHD patients

Eligibility Criteria

• Age: 7 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ADHD diagnosis according to DSM-IV-TR criteria
• Beneficiary of a social security scheme
• Having undergone an oculomotor examination as part of their usual care
• Normal neurological examination

You may not qualify if:

• Intellectual Disability (IQ \< 70)
• Proven neurological pathology or identified genetic syndrome
• Vestibular pathology
• Ear, nose, and throat (ENT) pathology
• Neuro-ophthalmological pathology uncorrected by corrective glass (\<10/10 in binocular vision

Sponsors & Collaborators

• Centre Hospitalier Rouffach: lead

Study Sites (1)

Centre Hospitalier Rouffach

Rouffach, Alsace, 68250, France

RECRUITING

Related Publications (3)

• Munoz DP, Armstrong IT, Hampton KA, Moore KD. Altered control of visual fixation and saccadic eye movements in attention-deficit hyperactivity disorder. J Neurophysiol. 2003 Jul;90(1):503-14. doi: 10.1152/jn.00192.2003. Epub 2003 Apr 2.

  PMID: 12672781 BACKGROUND

• Kurscheidt JC, Peiler P, Behnken A, Abel S, Pedersen A, Suslow T, Deckert J. Acute effects of methylphenidate on neuropsychological parameters in adults with ADHD: possible relevance for therapy. J Neural Transm (Vienna). 2008;115(2):357-62. doi: 10.1007/s00702-008-0871-4. Epub 2008 Feb 12.

  PMID: 18264813 BACKGROUND

• Duval F, Erb A, Mokrani MC, Weiss T, Carcangiu R. First-Dose Methylphenidate-Induced Changes in the Anti-Saccade Task Performance and Outcome in Adults with Attention-Deficit/Hyperactivity Disorder. Psychiatr Res Clin Pract. 2021 May 19;3(4):146-152. doi: 10.1176/appi.prcp.20210010. eCollection 2021 Winter.

  PMID: 36101656 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fabrice Duval

  Centre Hospitalier Rouffach

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice Duval, MD

CONTACT

33389787018; f.duval@ch-rouffach.fr

Alexis Erb, MD

CONTACT

33389787018; a.erb@ch-rouffach.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Psychiatrist

Model Details: Interventional study designed to evaluate routine care. The patients are their own controls. Oculomotor and neurocognitive performances are assessed at baseline (V0), during the methylphenidate test (V1), and after 6 months of methylphenidate treatment

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 26, 2018
• Study Start: February 17, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)