Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management

Phase

N/A

Condition

Dyskinesias

Manic Disorders

Williams Syndrome

Treatment

Assessment of executive functions

Clinical Scales

Medical consultation

Clinical Study ID

NCT01823354

8964

Ages 18-66
All Genders
Accepts Healthy Volunteers

Study Summary

Restless leg syndrome (RLS) is a common neurological disorder whose diagnosis is only clinical. The efficacy of dopaminergic agents in improvement of sensorimotor symptoms advance the hypothesis that altered dopaminergic transmission is at the origin of this condition. RLS usually leads to a sleep fragmentation, which induces sometimes severe insomnia most often associated, in clinical practice, to a cognitive complaint (attentional in nature). Executive functions in which dopaminergic transmission is heavily involved refer to a set of complex functions. At least three of them should be considered during their evaluation (ie flexibility, inhibition, and the updating of working memory). These functions are among the targets of the alteration of the quality and quantity of sleep. The few studies that have focused on the study of the integrity of executive functions in RLS have discordant results. The lack of control of key variables in the assessment of executive functioning (ie intellectual performance, depressive symptomatology, generalized slowing in information processing) and the lack of reference in the theoretical approach in executive functions are certainly the two main reasons. Moreover, the question of polysomnographic correlates and the reversibility of these cognitive abnormalities after pharmacological management of RLS remains unanswered today.

The main objective of this study is to compare the executive performance of untreated RLS patients with a group of matched controls.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Non-specific criteria (patients and controls)
Age: 18 to 70 years old
Fluency in French (written and oral);
intellectual performance within the normal range (f-NART> 84)
Subject has signed and returned to the investigator a copy of the signed informedconsent; .Affiliated to a social security scheme.
Specific criteria patients
Response to the diagnostic criteria established by the standards of the ICSD-II (2005) and IRLS Study Group (2003) with a severity scale listed at least 21 (score at least severe);
MPMS score> 10 / h; .ferritin > 50 ng/ml.

Exclusion

Exclusion Criteria:

Exclusion criteria (patients and controls)
Taking any psychotropic medication within 15 days prior to polysomnography (except for patients on dopamine agonist reassessed at 6 months follow-up);
Pregnant and lactating women;
Pneumologic affection
Night shift;
Apnea-hypopnea index > 15; .Major subjects protected by the law, underguardianship.
Exclusion criteria (controls)
Neurological or psychiatric current and/or past;
MPMS score> 10 / h; .Subject currently participating in another clinical researchproject prohibiting joint participation in another biomedical research, or whoare in a period of exclusion or who have already received the maximum legalcompensation for stresses in the year.
Exclusion criteria (patients)
Presence of other neurological conditions present and / or a psychiatric disorder (other than a mood disorder and / or anxiety); .RLS patients previously treatedwith a dopamine agonist who has not stopped treatment at least 15 days before thestart of the study.

Study Design

Assessment of executive functions

November 26, 2012

May 26, 2026

Connect with a study center

UH Montpellier
Montpellier, 34295
France
Active - Recruiting
UH Nîmes
Nîmes, 30209
France
Site Not Available

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