Periodic Limb Movement DisorderNCT04569643
Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease.
An observational study of Periodic Limb Movement Disorder and Cerebral Small Vessel Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Patients from 60 to 75 years old diagnosed with cerebral small vessel disease with no history of symptomatic stroke, brain tumor, traumatic brain injury, seizures and neurodegenerative or mental disorder will undergo overnight leg actigraphy and cardiorespiratory monitoring. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Periodic Limb Movement Disorder, Cerebral Small Vessel Diseases, Cognitive Dysfunction
- What is being tested?
- Actigraphy, Cardiorespiratory monitoring and Neuroimaging
- How many people
- 76 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2020to 31 Aug 2022
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with сerebral small vessel disease will be recruited among in-hospital patients (1st and 2nd Department of Neurology, University clinic 3, Sechenov First Moscow State Medical University, Moscow).
Who may be able to join
- Diagnosis of a cerebral small vessel disease - assessed by MRI.
- Ability to follow the procedures of the study, fluent Russian language - assessed by self-report.
Who cannot join
- History of symptomatic stroke, brain tumor or traumatic brain injury - assessed by self-report and clinical history.
- History of severe psychiatric comorbidities other than anxiety and depression, substance use disorder - assessed by self-report and clinical history.
- Significant visual loss (leading to difficulties with performing cognitive tasks) - assessed by self-report and clinical history.
- Presence of dementia - assessed by history and clinical examination.
- Movement disorders (e.g. tremor, dystonia etc.) leading to lower velocity of performing cognitive tasks against the clock - assessed by clinical examination.
- Obstructive sleep apnea syndrome - according to the criteria of International classification of sleep disorders III.
- Restless legs syndrome - according to the criteria of the International restless legs syndrome study group.
- Current intake of neuroleptics, benzodiazepines, selective serotonin reuptake inhibitors - assessed by self-report and clinical history.
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
About this study
Official title: Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease: a Clinical and Neuropsychological Study.
Patients from 60 to 75 years old diagnosed with cerebral small vessel disease with no history of symptomatic stroke, brain tumor, traumatic brain injury, seizures and neurodegenerative or mental disorder will undergo overnight leg actigraphy and cardiorespiratory monitoring. Those of them with apnea/hypopnea index under 5 will be enrolled. Brain MRI and cognitive assessment will be performed at baseline and in 1-year follow-up, sleep quality will be assessed at baseline with self-reported questionnaires. Progression of cerebral small vessel disease markers and cognitive dysfunction will be compared between patients with high periodic limb movement index (the number of periodic limb movement ≥ 15 per hour of sleep) and controls (periodic limb movement index < 15/h).
- Being tested
- Actigraphy, Cardiorespiratory monitoring, Neuroimaging, Assessment of cognitive function, Sleep quality and mood questionnaires
- Keywords
- Aged, Cerebral Small Vessel Disease, Cognitive Dysfunction, Magnetic Resonance Imaging, Periodic Limb Movement Disorder, Sleep Disorder
- Medical subject headings
- Nocturnal Myoclonus Syndrome, Cerebral Small Vessel Diseases, Cognitive Dysfunction, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyDiagnostic test
Participants will undergo overnight leg actigraphy at baseline. Leg movements will be recorded bilaterally by actigraphic method with two ankle-worn recorders.
Cardiorespiratory monitoringDiagnostic test
All participants will be scanned for presence of sleep-related breathing disorders with a portable monitoring device at baseline. The compact screening device will be attached to the patient's wrist during the night sleep.
NeuroimagingDiagnostic test
All subjects will undergo brain MRI scanning at baseline and in 1-year follow-up. The imaging protocol will include axial T1, T2, T2*, FLAIR and diffusion-weighted imaging scans that will be made on a 3-Tesla scanner.
Assessment of cognitive functionOther
Assessment will take place at weeks 0 (baseline) and 52 (1 year follow-up). The neuropsychological protocol will be consist of Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic (as a part of the MoCA) and semantic verbal fluency assessment, Symbol Digit Modalities Test.
Sleep quality and mood questionnairesOther
Self-reporting scales and questionnaires will be used at baseline to assess sleep quality, daytime functioning and mood. The protocol includes the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Geriatric Depression Scale.
| Study group | Role | What they receive |
|---|---|---|
| Main | Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep. Receives: Diagnostic Test: Actigraphy; Diagnostic Test: Cardiorespiratory monitoring; Diagnostic Test: Neuroimaging; Other: Assessment of cognitive function; Other: Sleep quality and mood questionnaires | |
| Control | Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep. Receives: Diagnostic Test: Actigraphy; Diagnostic Test: Cardiorespiratory monitoring; Diagnostic Test: Neuroimaging; Other: Assessment of cognitive function; Other: Sleep quality and mood questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter hyperintensities volume change
All the images will be processed with online software pipeline to make an automated volumetric measurement of white matter hyperintensities. The volume of the white matter lesion will be calculated separately for the periventricular, juxtacortical, infratentorial and deep white matter areas as well as total volume of the lesion. Baseline volumes will be subtracted from follow-up volumes to obtain absolute white matter hyperintensities volume change.
Measured: 1 year
Degree of Cognitive Decline
The scores of cognitive tests (Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic and semantic verbal fluency assessment, Symbol Digit Modalities Test) at baseline will be subtracted from the corresponding baseline scores. The obtained difference reflects the degree of cognitive decline in 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Dec 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodic Limb Movement DisorderStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekaterina D. Spektor, M.D., Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569643
- Sponsor's protocol ID
- 2207
- Status last verified
- Aug 2020
- First submitted
- 24 Sep 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease: a Clinical and Neuropsychological Study.
- ClinicalTrials.gov ID
- NCT04569643
- Acronym / sponsor ID
- 2207
- Keywords
- Aged, Cerebral Small Vessel Disease, Cognitive Dysfunction, Magnetic Resonance Imaging, Periodic Limb Movement Disorder, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 30 Sep 2020 (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.
Patients from 60 to 75 years old diagnosed with cerebral small vessel disease with no history of symptomatic stroke, brain tumor, traumatic brain injury, seizures and neurodegenerative or mental disorder will undergo overnight leg actigraphy and cardiorespiratory monitoring. Those of them with apnea/hypopnea index under 5 will be enrolled. Brain MRI and cognitive assessment will be performed at baseline and in 1-year follow-up, sleep quality will be assessed at baseline with self-reported questionnaires. Progression of cerebral small vessel disease markers and cognitive dysfunction will be compared between patients with high periodic limb movement index (the number of periodic limb movement ≥ 15 per hour of sleep) and controls (periodic limb movement index < 15/h).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main | – | Diagnostic Test: Actigraphy, Diagnostic Test: Cardiorespiratory monitoring, Diagnostic Test: Neuroimaging, Other: Assessment of cognitive function, Other: Sleep quality and mood questionnairesPatients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep. |
| Control | – | Diagnostic Test: Actigraphy, Diagnostic Test: Cardiorespiratory monitoring, Diagnostic Test: Neuroimaging, Other: Assessment of cognitive function, Other: Sleep quality and mood questionnairesPatients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with сerebral small vessel disease will be recruited among in-hospital patients (1st and 2nd Department of Neurology, University clinic 3, Sechenov First Moscow State Medical University, Moscow).
Key inclusion criteria (2 listed)
- Diagnosis of a cerebral small vessel disease - assessed by MRI.
- Ability to follow the procedures of the study, fluent Russian language - assessed by self-report.
Key exclusion criteria (8 listed)
- History of symptomatic stroke, brain tumor or traumatic brain injury - assessed by self-report and clinical history.
- History of severe psychiatric comorbidities other than anxiety and depression, substance use disorder - assessed by self-report and clinical history.
- Significant visual loss (leading to difficulties with performing cognitive tasks) - assessed by self-report and clinical history.
- Presence of dementia - assessed by history and clinical examination.
- Movement disorders (e.g. tremor, dystonia etc.) leading to lower velocity of performing cognitive tasks against the clock - assessed by clinical examination.
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 |
|---|---|---|
| ActigraphyParticipants will undergo overnight leg actigraphy at baseline. Leg movements will be recorded bilaterally by actigraphic method with two ankle-worn recorders. | Diagnostic test | Control, Main |
| Cardiorespiratory monitoringAll participants will be scanned for presence of sleep-related breathing disorders with a portable monitoring device at baseline. The compact screening device will be attached to the patient's wrist during the night sleep. | Diagnostic test | Control, Main |
| NeuroimagingAll subjects will undergo brain MRI scanning at baseline and in 1-year follow-up. The imaging protocol will include axial T1, T2, T2*, FLAIR and diffusion-weighted imaging scans that will be made on a 3-Tesla scanner. | Diagnostic test | Control, Main |
| Assessment of cognitive functionAssessment will take place at weeks 0 (baseline) and 52 (1 year follow-up). The neuropsychological protocol will be consist of Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic (as a part of the MoCA) and semantic verbal fluency assessment, Symbol Digit Modalities Test. | Other | Control, Main |
| Sleep quality and mood questionnairesSelf-reporting scales and questionnaires will be used at baseline to assess sleep quality, daytime functioning and mood. The protocol includes the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Geriatric Depression Scale. | Other | Control, Main |
Primary outcome
White matter hyperintensities volume change
Time frame: 1 year
All the images will be processed with online software pipeline to make an automated volumetric measurement of white matter hyperintensities. The volume of the white matter lesion will be calculated separately for the periventricular, juxtacortical, infratentorial and deep white matter areas as well as total volume of the lesion. Baseline volumes will be subtracted from follow-up volumes to obtain absolute white matter hyperintensities volume change.
Degree of Cognitive Decline
Time frame: 1 year
The scores of cognitive tests (Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic and semantic verbal fluency assessment, Symbol Digit Modalities Test) at baseline will be subtracted from the corresponding baseline scores. The obtained difference reflects the degree of cognitive decline in 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Ekaterina D. Spektor, M.D. principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov 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 Periodic Limb Movement Disorder and Cerebral Small Vessel Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 8 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 21 Feb 2021. 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 Russia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White matter hyperintensities volume change (time frame: 1 year). The study lists 2 primary outcomes in all. 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 21 Feb 2021.