Actively Recruiting

Phase Not Applicable
Age: 18Years - 66Years
All Genders
Healthy Volunteers
NCT01823354

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

Age: 18Years - 66Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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