G25.81 G20
Conditions
Interventions
Group 1: Patients with idiopathic Restless Legs Syndrome (iRLS)
Patients with idiopathic RLS will undergo clinical and neuropsychological assessment as part of the registry study. Data collected incl
Sponsors
Uniklinik Köln Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with Restless Legs Syndrome: Eligible participants are patients with idiopathic or comorbid Restless Legs Syndrome who are able to provide informed consent and who fulfill the essential criteria of the International Restless Legs Syndrome Study Group, independent of treatment status. Additional requirements are sufficient German language skills, written informed consent, and no dependent relationship with the study investigators. Healthy control participants: Eligible participants are healthy control individuals without Restless Legs Syndrome, Parkinson’s disease, dementia, or other neurological or psychiatric disorders, who are able to provide informed consent. Additional requirements are sufficient German language skills, written informed consent, and no dependent relationship with the study investigators. Optional fMRI subproject: Participation in the imaging subproject is voluntary and only possible for eligible participants who already participate in the first part of the study and provide additional consent for the MRI examination. Participation in the fMRI subproject is not required for inclusion in the registry.
Exclusion criteria
Exclusion criteria: Patients with Restless Legs Syndrome: Exclusion criteria are lack of capacity to provide informed consent, age below 18 years, and accommodation in an institution by court or official order. Further exclusion criteria include severe cognitive impairment preventing reliable symptom reporting, hearing or visual impairments that substantially interfere with the assessment, severe internal medical disease in an unstable phase, and moderate or severe medical conditions that impair study participation. Healthy control participants: Exclusion criteria are age below 18 years, lack of capacity to provide informed consent, accommodation in an institution by court or official order, severe cognitive impairment, relevant hearing or visual impairments, severe internal medical disease in an unstable phase, or moderate to severe medical conditions that impair study participation. In addition, individuals with Restless Legs Syndrome, Parkinson’s disease, dementia, or other neurological or psychiatric disorders are excluded. Exclusion criteria for the MRI subproject: Claustrophobia; ferromagnetic or electronic implants in or on the body, for example pacemaker, artificial heart valve, or intracranial shunt; metal fragments in the eye or head; tattoo in the head or neck region or metal-containing permanent makeup; intrauterine device/copper intrauterine device; iron deficiency anemia with ferritin < 50 µg/l; renal insufficiency with glomerular filtration rate < 60 ml/min; malignant tumor disease with evidence of brain or spinal cord involvement; pregnancy; and lack of consent to be informed about incidental findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: Severity of Restless Legs Syndrome (RLS) and clinical manifestation of RLS symptoms. WHEN: In patients with RLS, at baseline and during annual follow-up assessments for up to 5 years. In healthy control participants, once at baseline. HOW: Assessed using the International Restless Legs Syndrome Rating Scale (IRLS), as well as standardized clinical history taking and clinical-neurological examination performed by a physician or trained study personnel. | — |
Secondary
| Measure | Time frame |
|---|---|
| WHAT: - Identification and characterization of clinical RLS subtypes, particularly according to age at onset, symptom presentation, disease severity, painfulness of symptoms, disease course, and treatment response. - Treatment effectiveness, adverse effects, augmentation, and treatment resistance related to pharmacological and non-pharmacological treatment approaches under routine clinical conditions. - Extent of non-motor symptoms, sleep disturbances, mood symptoms, impairment in daily activities, and quality of life. - Global cognition as well as specific cognitive domains, including attention, executive functions, memory, language, working memory, and visuospatial abilities. - Response inhibition and the ability to inhibit already prepared motor responses. WHEN: - At baseline and during annual follow-up assessments for up to 5 years; in healthy control participants, once at baseline. HOW: - Standardized RLS-related medical history, clinical examination, and documentation of disease course, comorbidities, and treatment. The registry explicitly aims to subtype and characterize symptom presentation, disease severity, and disease course. - Documentation of pharmacological treatment, clinical follow-up assessment, and standardized questionnaires, including the Augmentation Severity Rating Scale (ASRS) for the assessment of augmentation. - Standardized self-report questionnaires, including the Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL), Non-Motor Symptoms Questionnaire (NMSQuest), and Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH). - Standardized neuropsychological testing using the Montreal Cognitive Assessment (MoCA), Consortium to Establish a Registry for Alzheimer’s Disease (CERAD), Wechsler Adult Intelligence Scale – Fourth Edition (WAIS-IV), Digit Span subtest, and the Visual Object and Space Perception Battery (VOSP), Cube Analysis subtest. - Go/NoGo Task from the Test of Attentional Performanc | — |
Countries
Germany
Contacts
Public ContactAnna Sauerbier
Uniklinik Köln, Neurologie
Outcome results
None listed