Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder

NCT ID: NCT05573711

Last Updated: 2022-10-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-09-01

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.

Detailed Description

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Conditions

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Neuromyelitis Optica Restless Legs Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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assessments

Assessments, no specific intervention

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Serkan Ozakbas

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Serkan Ozakbas, MD

Role: CONTACT

0232 412 4964

Asiye Tuba Ozdogar, PhD

Role: CONTACT

Facility Contacts

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Serkan Ozakbas, MD

Role: primary

0232 412 4964

Asiye Tuba Ozdogar, PhD

Role: backup

Other Identifiers

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7304-GOA

Identifier Type: -

Identifier Source: org_study_id

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