Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05573711
Status:
UNKNOWN
Last Update Posted:
2022-10-10
First Post:
2022-10-06
Brief Title:
Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
Determination of the Frequency of Restless Legs Syndrome and Associated Factors in People With Neuromyelitis Optica Spectrum Disorder
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parkinsons 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None