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

NCT01823354 | Recruiting DMC

• 1 other identifier: 8964
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

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.

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndrome; Polysomnography; Executive cognition

Outcome Measures

Primary Outcomes (1)

• Comparison of the Verbal fluency test between untreated RLS patients and control subjects

  Number of correct words (without repetitions and intrusions) provided by the subject in each condition.

  Day 0

Secondary Outcomes (4)

• Change of the Clinical Scales at day 180 (composite criteria)

  Day 0 and day180

• Change of the sleep fragmentation at day 180 (composite criteria)

  Day 0 and Day 180

• Assessment of executive functions (composite criteria)

  Day 180

• Change of the Verbal fluency test after dopamin agonist treatment in RLS patients

  Day 0 and Day 180

Study Arms (2)

Patients

OTHER

Polysomnography, Assessment of executive functions, Clinical scales, Medical consultation

Other: Polysomnography; Other: Clinical Scales; Other: Assessment of executive functions; Other: Medical consultation

Controls

OTHER

Polysomnography, Assessment of executive functions, Clinical scales Medical consultation

Other: Polysomnography; Other: Clinical Scales; Other: Assessment of executive functions; Other: Medical consultation

Interventions

Polysomnography OTHER

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.

Controls; Patients

Clinical Scales OTHER

Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.

Controls; Patients

Assessment of executive functions OTHER

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).

Controls; Patients

Medical consultation OTHER

open questions

Controls; Patients

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Neurological or psychiatric current and/or past;
• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

UH Montpellier

Montpellier, 34295, France

RECRUITING

UH Nîmes

Nîmes, 30209, France

NOT YET RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Yves Dauvilliers, PU, PH

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Dauvilliers, PU, PH

CONTACT

+33 4 67 33 72 77; y-dauvilliers@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: April 4, 2013
• Study Start: November 26, 2012
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

FR (2)