Restless Legs Syndrome
Conditions
Keywords
Restless Legs Syndrome, Polysomnography, Executive cognition
Brief 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.
Interventions
OTHERPolysomnography
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.
OTHERClinical Scales
Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.
OTHERAssessment 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).
OTHERMedical consultation
open questions
Sponsors
University Hospital, Montpellier
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
Yes
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 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.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Verbal fluency test between untreated RLS patients and control subjects | Day 0 | Number of correct words (without repetitions and intrusions) provided by the subject in each condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Clinical Scales at day 180 (composite criteria) | Day 0 and day180 | * Index of Restless Legs Syndrome Severity * Index of insomnia Severity * Beck's Inventory of Depression * Anxiety Inventory: State-Trait, form Y |
| Change of the sleep fragmentation at day 180 (composite criteria) | Day 0 and Day 180 | The severity of sleep fragmentation is determined by these parameters: * Total time asleep in minutes. * Percentage of sleep efficiency. * Ensure intra-sleep. * Index of arousals / hour of sleep. * Index of periodic movements per hour of sleep associated with arousal * Index of arousal. |
| Assessment of executive functions (composite criteria) | Day 180 | * Trail Making Test GREFEX * Sroop Test GREFEX * Wisconsin Card Sorting Test * Phasic alertness TAP * Working memory TAP * Flexibility TAP * Go / no go TAP * Score of Reached Executive Severity |
| Change of the Verbal fluency test after dopamin agonist treatment in RLS patients | Day 0 and Day 180 | Number of correct words (without repetitions and intrusions) provided by the subject in each condition. |
Countries
France
Contacts
Primary ContactYves Dauvilliers, PU, PH
Outcome results
None listed