Neuromyelitis OpticaNCT05573711
Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder
An observational study of Neuromyelitis Optica and Restless Legs Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica, Restless Legs Syndrome
- What is being tested?
- assessments
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: people with neuromyelitis optica spectrum disorder
Who may be able to join
- Being diagnosed with NMOSD by a neurologist
- To be willing to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Asiye Tuba Ozdogar, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University
Izmir
Serkan Ozakbas, MD, 0232 412 4964, serkan.ozakbas@gmail.com
Asiye Tuba Ozdogar, PhD, tuba.ozdogar@yahoo.com
About this study
Official title: Determination of the Frequency of Restless Legs Syndrome and Associated Factors in People With Neuromyelitis Optica Spectrum Disorder
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.
Read more
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
- Being tested
- assessments
- Keywords
- sleep, neuromyelitis optica, cognitive functions
- Medical subject headings
- Neuromyelitis Optica, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentsOther
Assessments, no specific intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
Pittsburgh Sleep Quality Index
Detect sleep disturbances or deficits.
Measured: Baseline
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
Measured: Baseline
Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with a Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. Higher score indicates higher level of fatigue.
Measured: Baseline
Symbol Digit Modalities Test
The Symbol Digit Modalities Test is used to assess information processing speed. Using a reference key, the test taker has 90 seconds to pair specific numbers with given geometric figures in the Symbol Digit Modalities Test. The correct matches are calculated as the test score. Higher scores indicate better information processing speed.
Measured: Baseline
California Verbal Learning Test-II
The California Verbal Learning Test-II is used to assess verbal memory. Higher scores indicate better verbal memory.
Measured: Baseline
Revised Brief Visuospatial Memory Test
The Revised Brief Visuospatial Memory Test is used to assess visuospatial memory. Higher scores indicate better visuospatial memory.
Measured: Baseline
Magnetic Resonance Imagery
The MRI results of the people with NMOSD included in the study, taken within the last 6 months, will be examined. Black hole, active lesion and spinal lesion presence, region and number will be noted. MRI results will be evaluated by neurologists specialized in demyelinating diseases.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis OpticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Ozakbas, Dokuz Eylul University
- Investigators
- Serkan Ozakbas, MD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573711
- Sponsor's protocol ID
- 7304-GOA
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Frequency of Restless Legs Syndrome and Associated Factors in People With Neuromyelitis Optica Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05573711
- Acronym / sponsor ID
- 7304-GOA
- Conditions
- Neuromyelitis Optica, Restless Legs Syndrome
- Keywords
- sleep, neuromyelitis optica, cognitive functions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- people with neuromyelitis optica spectrum disorder
Key inclusion criteria (2 listed)
- Being diagnosed with NMOSD by a neurologist
- To be willing to participate in the study.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessmentsAssessments, no specific intervention | Other | – |
Primary outcome
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
Time frame: Baseline
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.
7 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Baseline
Epworth Sleepiness Scale
Time frame: Baseline
Modified Fatigue Impact Scale
Time frame: Baseline
Symbol Digit Modalities Test
Time frame: Baseline
California Verbal Learning Test-II
Time frame: Baseline
Revised Brief Visuospatial Memory Test
Time frame: Baseline
Magnetic Resonance Imagery
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asiye Tuba Ozdogar, PhD contact
Serkan Ozakbas, MD principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica and Restless Legs Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serkan Ozakbas, MD (0232 412 4964, serkan.ozakbas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.