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

Restless Legs Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01823354
• Other study ID #: 8964
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2012
• Est. completion date: May 26, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Yves Dauvilliers, PU, PH
• Phone: +33 4 67 33 72 77
• Email: y-dauvilliers[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: May 26, 2026
• Est. primary completion date: May 26, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Other:
• Polysomnography
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.
• Clinical Scales
Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.
• Assessment 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).
• Medical consultation
open questions

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier
France	UH Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of the Clinical Scales at day 180 (composite criteria)	Index of Restless Legs Syndrome Severity; Index of insomnia Severity; Beck's Inventory of Depression; Anxiety Inventory: State-Trait, form Y	Day 0 and day180
Secondary	Change of the sleep fragmentation at day 180 (composite criteria)	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.	Day 0 and Day 180
Secondary	Assessment of executive functions (composite criteria)	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	Day 180
Secondary	Change of the Verbal fluency test after dopamin agonist treatment in RLS patients	Number of correct words (without repetitions and intrusions) provided by the subject in each condition.	Day 0 and Day 180