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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01823354
First received: March 22, 2013
Last updated: April 2, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Restless Legs Syndrome
Other: Polysomnography
Other: Clinical Scales
Other: Assessment of executive functions
Other: Medical consultation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Executive Dysfunction in Restless Legs Syndrome: Determination of Clinical Correlates and Outcome After Therapeutic Management

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • change of the Verbal fluency test at Day 180 [ Time Frame: Day 0 and Day 180 ] [ Designated as safety issue: No ]
    Number of correct words (without repetitions and intrusions) provided by the subject in each condition.


Secondary Outcome Measures:
  • change of the Clinical Scales at day 180 (composite criteria) [ Time Frame: Day 0 and day180 ] [ Designated as safety issue: No ]
    • Index of Restless Legs Syndrome Severity
    • Index of insomnia Severity
    • Beck's Inventory of Depression
    • Anxiety Inventory: State-Trait, form Y

  • change of the sleep fragmentation at day 180 (composite criteria) [ Time Frame: Day 0 and Day 180 ] [ Designated as safety issue: No ]

    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.

  • Assessment of executive functions (composite criteria) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 140
Study Start Date: November 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients
Polysomnography, Assessment of executive functions, Clinical scales, Medical consultation
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.
Other: Clinical Scales
Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.
Other: 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).
Other: Medical consultation
open questions
Controls
Polysomnography, Assessment of executive functions, Clinical scales Medical consultation
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.
Other: Clinical Scales
Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.
Other: 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).
Other: Medical consultation
open questions

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-specific criteria (patients and controls)

    • Age: 18 to 66 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> 10; .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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823354

Contacts
Contact: Yves Dauvilliers, PU, PH +33 4 67 33 72 77 y-dauvilliers@chu-montpellier.fr

Locations
France
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Claire Chauveton    +33 467330924    c-chauveton@chu-montpellier.fr   
Principal Investigator: Yves Dauvilliers, PU, PH         
Sub-Investigator: Bertrand CARLANDER, PH         
UH Nîmes Not yet recruiting
Nîmes, France, 30209
Contact: Giovanni CASTELNOVO, PH         
Principal Investigator: Giovanni CASTELNOVO, PH         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Yves Dauvilliers, PU, PH UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01823354     History of Changes
Other Study ID Numbers: 8964
Study First Received: March 22, 2013
Last Updated: April 2, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Montpellier:
Restless Legs Syndrome
Polysomnography
Executive cognition

Additional relevant MeSH terms:
Restless Legs Syndrome
Syndrome
Psychomotor Agitation
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014