NCT01823354

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Accepted

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.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
OTHER	Polysomnography	Polysomnography involves the collection of the electroencephalogram, electromyogram of, and electro-oculogram to differentiate the various stages of sleep. Determination of different stages and cycles of sleep will be manually by reading the EEG, EMG, EOG over periods of 30 seconds after the standardized criteria of AASM (American Academy of Sleep Medicine). Registration will take place between sleep and 23h 7am.
OTHER	Clinical Scales	Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.
OTHER	Assessment of executive functions	Verbal fluencies Test GREFEX (Assessment of the spontaneous flexibility), Stroop Test GREFEX (Inhibition of the automatic response Capacity ), Trail Making Test GREFEX (Assessment of flexibility "reactive"), Wisconsin Card Sorting Test(Overall assessment of executive functions), Working memory TAP, Flexibility TAP, Go/no go TAP, Phasic alertness (Assessment of speed information processing).
OTHER	Medical consultation	open questions

Timeline

• Start date: 2012-11-26
• Primary completion: 2026-05-26
• Completion: 2026-05-26
• First posted: 2013-04-04
• Last updated: 2024-05-03

Locations

2 sites across 1 country: France