Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder

Study Overview
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Brief Summary
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Restless legs syndrome (RLS) is a neurological movement disorder characterized by uncomfortable and uncontrollable sensations, usually in the legs, that increase at rest, and an urge to move the legs or other affected extremities. The exact cause of RLS is unknown, but there are idiopathic and secondary forms of RLS associated with various medical conditions such as anemia, pregnancy, uremia, neuropathies, rheumatoid arthritis, parkinson's disease, spinocerebellar ataxia, and neurological disorders such as multiple sclerosis. Neuromyelitis optica (NMO) is a severe inflammatory disease of the central nervous system. NMO, once considered a variant of multiple sclerosis, is now recognized as a separate disease entity. In 2004, the water channel protein-specific antibody called aquaporin 4 (AQP4) was found to cause NMO, leading to the identification of NMO as a separate disease. When initially described, the disease was thought to show only necrotic and demyelinating lesions in the optic nerve and spinal cord. It was therefore thought that NMO would preferentially only attack the optic nerves and spinal cord, not the brain. However, over the years, evidence from various studies has proven that various parts of the brain are also affected during the course of the disease. In addition, some patients showing features of the disease were found to be seronegative for anti-AQP4 antibodies. These findings necessitated the need to introduce a new term neuromyelitis optica spectrum disorders (NMOSD) to describe all the features of the disease. Although the feeling of restlessness in the legs is frequently reported as a sensory symptom by people with NMOSD, there are limited publications to investigate the relationship between RLS and NMOSD. The primary aim of the study is to determine the frequency and severity of RLS in people with NMOSD. The second aim of the study is to compare the presence and severity of RLS, sleep quality, daytime sleepiness level, quality of life, fatigue and Magnetic Resonance Imaging (MRI) results in people with NMOSD. The third aim of the study is to compare the cognitive functions of people with RLS positive and negative NMOSD. People with NMOSD who came to Dokuz Eylul University Medical Faculty Hospital Neurology Department MS Polyclinic for their routine check-ups, who volunteered to participate, will be included in the study.

Official Title
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Determination of the Frequency of Restless Legs Syndrome and Associated Factors in People With Neuromyelitis Optica Spectrum Disorder

Conditions
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Neuromyelitis Optica, Restless Legs Syndrome

Intervention / Treatment
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* Other: assessments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with NMOSD by a neurologist To be willing to participate in the study. Exclusion Criteria: Diagnosed severe cognitive and/or psychiatric impairment Having any of the conditions known to be associated with RLS, such as anemia [hemoglobin (Hb) levels <12 mg/mL], pregnancy, uremia, neuropathies, rheumatoid arthritis, and neurological diseases other than NMOSD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: assessments|Assessments, no specific intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Restless Legs Syndrome Study Group rating scale for restless legs syndrome | The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | Detect sleep disturbances or deficits. | Baseline | 
| Epworth Sleepiness Scale | The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. | Baseline | 
| Modified Fatigue Impact Scale | The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with a Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. Higher score indicates higher level of fatigue. | Baseline | 
| Symbol Digit Modalities Test | The Symbol Digit Modalities Test is used to assess information processing speed. Using a reference key, the test taker has 90 seconds to pair specific numbers with given geometric figures in the Symbol Digit Modalities Test. The correct matches are calculated as the test score. Higher scores indicate better information processing speed. | Baseline | 
| California Verbal Learning Test-II | The California Verbal Learning Test-II is used to assess verbal memory. Higher scores indicate better verbal memory. | Baseline | 
| Revised Brief Visuospatial Memory Test | The Revised Brief Visuospatial Memory Test is used to assess visuospatial memory. Higher scores indicate better visuospatial memory. | Baseline | 
| Magnetic Resonance Imagery | The MRI results of the people with NMOSD included in the study, taken within the last 6 months, will be examined. Black hole, active lesion and spinal lesion presence, region and number will be noted. MRI results will be evaluated by neurologists specialized in demyelinating diseases. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, neuromyelitis optica, cognitive functions