STUDY OBJECTIVES: Restless legs syndrome (RLS) has a prevalence of 0% to 52% in Parkinson disease (PD). However, it is still debated whether RLS in PD is a premotor feature, a motor complication, or an association by chance. The present study aims to evaluate RLS prevalence in de novo PD subjects, and incidence during 4-year follow-up, together with laboratory, clinical, and neuroradiological correlates. DESIGN: This is a 4-year longitudinal study, with evaluations at the time of PD diagnosis, and after 2 and 4 years. SETTING AND PATIENTS: One hundred nine newly diagnosed, drug-naive PD subjects were evaluated at the time of PD diagnosis, and after 2- and 4-year follow-ups at the Movement Disorder Unit of Federico II University Hospital, Naples, Italy. INTERVENTIONS: Motor features, non-motor symptoms (NMS), concomitant dopaminergic and non-dopaminergic treatments were recorded. At baseline visit, 65 subjects were randomly selected to undergo a FP-CIT SPECT to study dopamine transporter availability. RLS diagnosis was performed with the RLS Diagnostic Index. MEASUREMENTS AND RESULTS: RLS prevalence rose from 4.6% (n = 5) at baseline evaluation to 6.5% after 2 years (n = 7) and to 16.3% after 4 years (n = 16) (P = 0.007). A multinomial logistic stepwise regression model selected NMS Questionnaire items more likely to be associated with RLS at diagnosis: (insomnia, OR = 15.555; P = 0.040) and with occurrence of RLS during follow-up (dizziness, OR=1.153; P = 0.022; and daytime sleepiness; OR = 9.557; P = 0.001), as compared to patients without RLS. Older age was more likely associated to increased RLS occurrence during follow-up in a random effect logistic regression model (OR=1.187; P = 0.036). A multinomial logistic stepwise model selected increased V3" values of affected caudate and putamen to be more likely associated with RLS presence at diagnosis (OR = 75.711; P = 0.077), and RLS occurrence during follow-up (OR = 12.004; P = 0.059), respectively, as compared to patients without RLS. CONCLUSIONS: RLS is present since PD diagnosis, and increases in prevalence during the course of PD. PD subjects with RLS have higher age at PD onset, more preserved dopaminergic pathways, and worse sleep and cardiovascular disturbances.
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