Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder
NCT ID: NCT05573711
Last Updated: 2022-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2022-10-01
2023-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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assessments
Assessments, no specific intervention
Eligibility Criteria
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Inclusion Criteria
* To be willing to participate in the study.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Dokuz Eylul University
OTHER
Responsible Party
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Serkan Ozakbas
MD
Principal Investigators
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Serkan Ozakbas, MD
Role: PRINCIPAL_INVESTIGATOR
Dokuz Eylul University
Locations
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Dokuz Eylul University
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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7304-GOA
Identifier Type: -
Identifier Source: org_study_id
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