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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 66
Healthy Volunteers: t
View:

• 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 informed consent; .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.

Locations
Other Locations
France
UH Montpellier
RECRUITING
Montpellier
UH Nîmes
NOT_YET_RECRUITING
Nîmes
Contact Information
Primary
Yves Dauvilliers, PU, PH
y-dauvilliers@chu-montpellier.fr
+33 4 67 33 72 77
Time Frame
Start Date: 2012-11-26
Estimated Completion Date: 2026-05-26
Participants
Target number of participants: 176
Treatments
Other: Patients
Polysomnography, Assessment of executive functions, Clinical scales, Medical consultation
Other: Controls
Polysomnography, Assessment of executive functions, Clinical scales Medical consultation
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov