Clinical trial NCT01823354: Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management
Official title: Executive Dysfunction in Restless Legs Syndrome: Determination of Clinical Correlates and Outcome After Therapeutic Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Restless Legs Syndrome
Keywords: Restless Legs Syndrome
Polysomnography
Executive cognition
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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:

* 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, under guardianship.
* Exclusion criteria (controls)

  * Neurological or psychiatric current and/or past;
  * MPMS score\> 10 / h; .Subject currently participating in another clinical research project prohibiting joint participation in another biomedical research, or who are in a period of exclusion or who have already received the maximum legal compensation 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 treated with a dopamine agonist who has not stopped treatment at least 15 days before the start of the study.

Primary outcomes:
measure: Comparison of the Verbal fluency test between untreated RLS patients and control subjects
timeFrame: Day 0
Secondary outcomes:
measure: Change of the Clinical Scales at day 180 (composite criteria)
timeFrame: Day 0 and day180
measure: Change of the sleep fragmentation at day 180 (composite criteria)
timeFrame: Day 0 and Day 180
measure: Assessment of executive functions (composite criteria)
timeFrame: Day 180
measure: Change of the Verbal fluency test after dopamin agonist treatment in RLS patients
timeFrame: Day 0 and Day 180
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
city: Nîmes
country: France
facility: UH Nîmes
Study officials:
affiliation: UH Montpellier
name: Yves Dauvilliers, PU, PH
role: PRINCIPAL_INVESTIGATOR
References: