Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder

NCT05573711 | Unknown

• 1 other identifier: 7304-GOA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromyelitis Optica; Restless Legs Syndrome

Keywords

sleep; neuromyelitis optica; cognitive functions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pittsburgh Sleep Quality Index

  Baseline

• Epworth Sleepiness Scale

  Baseline

• Modified Fatigue Impact Scale

  Baseline

• Symbol Digit Modalities Test

  Baseline

• California Verbal Learning Test-II

  Baseline

Other Outcomes (2)

• Restless Legs Syndrome Diagnostic Criteria

  Baseline

• Expanded Disability Status Scale

  Baseline

Interventions

assessments OTHER

Assessments, no specific intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

people with neuromyelitis optica spectrum disorder

You may qualify if:

• Being diagnosed with NMOSD by a neurologist
• To be willing to participate in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica; Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Serkan Ozakbas, MD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serkan Ozakbas, MD

CONTACT

0232 412 4964; serkan.ozakbas@gmail.com

Asiye Tuba Ozdogar, PhD

CONTACT

tuba.ozdogar@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: October 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

TU (1)