Actively Recruiting
Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management
Led by University Hospital, Montpellier · Updated on 2024-05-03
176
Participants Needed
2
Research Sites
704 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Fluent in French, both written and spoken
- Intellectual performance within the normal range (f-NART > 84)
- Signed and returned informed consent
- Affiliated with a social security scheme
- For patients: diagnosed with RLS according to ICSD-II (2005) and IRLS Study Group (2003) criteria with severity score at least 21 (severe)
- For patients: MPMS score greater than 10 per hour
- For patients: ferritin level greater than 50 ng/ml
You will not qualify if you...
- Taking any psychotropic medication within 15 days before polysomnography (except dopamine agonist patients reassessed at 6 months)
- Pregnant or lactating women
- Having a lung disease
- Working night shifts
- Apnea-hypopnea index greater than 15
- Legal protection under guardianship
- For controls: current or past neurological or psychiatric disorders
- For controls: MPMS score greater than 10 per hour
- For controls: currently participating in another clinical trial prohibiting joint participation
- For patients: other neurological or psychiatric conditions (except mood or anxiety disorders)
- For patients: previously treated with dopamine agonist and not stopped treatment at least 15 days before study start
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UH Montpellier
Montpellier, France, 34295
Actively Recruiting
2
UH Nîmes
Nîmes, France, 30209
Not Yet Recruiting
Research Team
Y
Yves Dauvilliers, PU, PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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