Restless Legs SyndromeNCT01823354
Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management
A study testing Polysomnography, Clinical Scales and Assessment of executive functions in people with Restless Legs Syndrome, run by University Hospital, Montpellier at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Polysomnography, Clinical Scales and Assessment of executive functions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Nov 2012to 26 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Claire Chauveton, +33 467330924, c-chauveton@chu-montpellier.fr
Yves Dauvilliers, PU, PH
- Not yet recruiting
UH Nîmes
Nîmes, 30209
Giovanni CASTELNOVO, PH
Giovanni CASTELNOVO, PH
About this study
Official title: Executive Dysfunction in Restless Legs Syndrome: Determination of Clinical Correlates and Outcome After Therapeutic Management
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
- Being tested
- Polysomnography, Clinical Scales, Assessment of executive functions, Medical consultation
- Keywords
- Restless Legs Syndrome, Polysomnography, Executive cognition
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
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 ScalesOther
Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.
Assessment of executive functionsOther
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 consultationOther
open questions
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Polysomnography, Assessment of executive functions, Clinical scales, Medical consultation Receives: Other: Polysomnography; Other: Clinical Scales; Other: Assessment of executive functions; Other: Medical consultation |
| Controls | Other | Polysomnography, Assessment of executive functions, Clinical scales Medical consultation Receives: Other: Polysomnography; Other: Clinical Scales; Other: Assessment of executive functions; Other: Medical consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
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
Measured: Day 0 and day180
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.
Measured: Day 0 and Day 180
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
Measured: Day 180
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.
Measured: Day 0 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start26 Nov 2012
- Primary completion26 May 2026 (estimated)
- Study completion26 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Dauvilliers, PU, PH, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823354
- Sponsor's protocol ID
- 8964
- Status last verified
- May 2024
- First submitted
- 22 Mar 2013
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Dysfunction in Restless Legs Syndrome: Determination of Clinical Correlates and Outcome After Therapeutic Management
- ClinicalTrials.gov ID
- NCT01823354
- Acronym / sponsor ID
- 8964
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Polysomnography, Executive cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 26 Nov 2012 (actual)
- Primary completion
- 26 May 2026 (estimated)
- Study completion
- 26 May 2026 (estimated)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Polysomnography, Other: Clinical Scales, Other: Assessment of executive functions, Other: Medical consultationPolysomnography, Assessment of executive functions, Clinical scales, Medical consultation |
| Controls | Other | Other: Polysomnography, Other: Clinical Scales, Other: Assessment of executive functions, Other: Medical consultationPolysomnography, Assessment of executive functions, Clinical scales Medical consultation |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Non-specific criteria (patients and controls)
- Specific criteria patients
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyPolysomnography 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 | Controls, Patients |
| Clinical ScalesIndex of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y. | Other | Controls, Patients |
| Assessment of executive functionsVerbal 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 | Controls, Patients |
| Medical consultationopen questions | Other | Controls, Patients |
Primary outcome
Comparison of the Verbal fluency test between untreated RLS patients and control subjects
Time frame: Day 0
Number of correct words (without repetitions and intrusions) provided by the subject in each condition.
4 secondary outcomes
Change of the Clinical Scales at day 180 (composite criteria)
Time frame: Day 0 and day180
Change of the sleep fragmentation at day 180 (composite criteria)
Time frame: Day 0 and Day 180
Assessment of executive functions (composite criteria)
Time frame: Day 180
Change of the Verbal fluency test after dopamin agonist treatment in RLS patients
Time frame: Day 0 and Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Dauvilliers, PU, PH principal investigator
UH Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography, Clinical Scales and Assessment of executive functions in people with Restless Legs Syndrome, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves Dauvilliers, PU, PH (+33 4 67 33 72 77, y-dauvilliers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Verbal fluency test between untreated RLS patients and control subjects (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.