Clinical trial NCT05573711: Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder
Official title: Determination of the Frequency of Restless Legs Syndrome and Associated Factors in People With Neuromyelitis Optica Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuromyelitis Optica
Restless Legs Syndrome
Keywords: sleep
neuromyelitis optica
cognitive functions
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with neuromyelitis optica spectrum disorder

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
timeFrame: Baseline
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Modified Fatigue Impact Scale
timeFrame: Baseline
measure: Symbol Digit Modalities Test
timeFrame: Baseline
measure: California Verbal Learning Test-II
timeFrame: Baseline
measure: Revised Brief Visuospatial Memory Test
timeFrame: Baseline
measure: Magnetic Resonance Imagery
timeFrame: Baseline
Other outcomes:
measure: Restless Legs Syndrome Diagnostic Criteria
timeFrame: Baseline
measure: Expanded Disability Status Scale
timeFrame: Baseline
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Serkan Ozakbas, MD
role: PRINCIPAL_INVESTIGATOR
References: