Status:
RECRUITING
Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-66 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 26 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT01823354
Start Date
November 26 2012
End Date
May 26 2026
Last Update
May 3 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
UH Montpellier
Montpellier, France, 34295
2
UH Nîmes
Nîmes, France, 30209