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Search / Trial NCT01823354

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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Apr 2, 2013

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Restless Legs Syndrome Polysomnography Executive Cognition

ClinConnect Summary

This clinical trial is studying how Restless Legs Syndrome (RLS) affects a person's ability to perform complex mental tasks, which is known as executive functioning. Researchers want to compare the executive performance of individuals with untreated RLS to a group of people without the condition. They believe that the difficulties in attention and sleep associated with RLS could impact how well someone can think, plan, and remember information. The study aims to better understand these connections and how treatment might help improve cognitive function in RLS patients.

To participate in the trial, individuals must be between 18 and 70 years old, fluent in French, and have normal intellectual performance. Patients must also meet specific criteria for RLS severity. However, people with certain health conditions, those taking specific medications, or those who are pregnant cannot participate. Participants can expect to undergo assessments to evaluate their cognitive abilities and sleep patterns. This research is crucial as it may lead to better understanding and treatment options for RLS, ultimately improving the quality of life for those affected.

Gender

ALL

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.

About University Hospital, Montpellier

The University Hospital of Montpellier is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its commitment to patient-centered care, the hospital collaborates with multidisciplinary teams to explore cutting-edge treatments and therapies across various medical fields. By integrating clinical practice with education and research, the University Hospital of Montpellier aims to enhance health outcomes and contribute to the scientific community's understanding of complex medical conditions. Its robust infrastructure and expertise make it a pivotal player in the landscape of clinical research.

Locations

Montpellier, , France

Nîmes, , France

Patients applied

0 patients applied

Trial Officials

Yves Dauvilliers, PU, PH

Principal Investigator

UH Montpellier

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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