Understanding executive dysfunction in restless legs syndrome and its treatment outcomes
Executive Dysfunction in Restless Legs Syndrome: Determination of Clinical Correlates and Outcome After Therapeutic Management
This study is trying to see how problems with thinking and decision-making affect people with restless legs syndrome and if treatment can help improve these issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 66 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT01823354 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between executive dysfunction and restless legs syndrome (RLS), a neurological disorder characterized by uncomfortable sensations in the legs and an uncontrollable urge to move them. It aims to assess executive functions, such as flexibility and working memory, in patients diagnosed with RLS and evaluate the impact of therapeutic management on these cognitive functions. The methodology includes polysomnography and clinical assessments to gather data on sleep quality and cognitive performance. By exploring these correlations, the study seeks to provide insights into the cognitive complaints often associated with RLS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 who are fluent in French and have a confirmed diagnosis of severe restless legs syndrome.
Not a fit: Patients with significant comorbidities, such as severe sleep apnea or those on psychotropic medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies for managing cognitive symptoms in patients with restless legs syndrome.
How similar studies have performed: While there have been few studies on executive functions in RLS, the results have been inconsistent, indicating that this approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier and 1 other locations
- UH Montpellier — Montpellier, France (Recruiting)
- UH Nîmes — Nîmes, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Yves Dauvilliers, PU, PH — UH Montpellier
- Study coordinator: Yves Dauvilliers, PU, PH
- Email: y-dauvilliers@chu-montpellier.fr
- Phone: +33 4 67 33 72 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.