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

Primary Purpose

Restless Legs Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Polysomnography

Clinical Scales

Assessment of executive functions

Medical consultation

About this trial

This is an interventional other trial for Restless Legs Syndrome focused on measuring Restless Legs Syndrome, Polysomnography, Executive cognition

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UH MontpellierRecruiting
UH Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Patients

Controls

Arm Description

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

Polysomnography, Assessment of executive functions, Clinical scales Medical consultation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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

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.

Full Information

NCT ID

NCT01823354

First Posted

March 22, 2013

Last Updated

October 2, 2020

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT01823354

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2012 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

Keywords

Restless Legs Syndrome, Polysomnography, Executive cognition

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Other

Arm Description

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

Arm Title

Controls

Arm Type

Other

Arm Description

Polysomnography, Assessment of executive functions, Clinical scales Medical consultation

Intervention Type

Other

Intervention Name(s)

Polysomnography

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Clinical Scales

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Assessment of executive functions

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Medical consultation

Intervention Description

open questions

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 0

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 0 and day180

Title

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

Description

Time Frame

Day 0 and Day 180

Title

Assessment of executive functions (composite criteria)

Description

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

Time Frame

Day 180

Title

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

Description

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

Time Frame

Day 0 and Day 180

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

66 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yves Dauvilliers, PU, PH

Phone

+33 4 67 33 72 77

y-dauvilliers@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves Dauvilliers, PU, PH

Organizational Affiliation

UH Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claire Chauveton

Phone

+33 467330924

c-chauveton@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Yves Dauvilliers, PU, PH

First Name & Middle Initial & Last Name & Degree

Bertrand CARLANDER, PH

Facility Name

UH Nîmes

City

Nîmes

ZIP/Postal Code

30209

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giovanni CASTELNOVO, PH

First Name & Middle Initial & Last Name & Degree

Giovanni CASTELNOVO, PH

12. IPD Sharing Statement

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

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