Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease.

• Conditions: Periodic Limb Movement Disorder; Cognitive Dysfunction; Cerebral Small Vessel Diseases
• Interventions: Diagnostic Test: Actigraphy; Diagnostic Test: Cardiorespiratory monitoring; Diagnostic Test: Neuroimaging; Other: Assessment of cognitive function; Other: Sleep quality and mood questionnaires

• Registration Number: NCT04569643
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Study Start: 2020-12-01
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21
• Primary Completion: 2022-04-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main	Neuroimaging	Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep.
Main	Assessment of cognitive function	Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep.
Control	Neuroimaging	Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep.
Main	Actigraphy	Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep.
Main	Cardiorespiratory monitoring	Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep.
Control	Actigraphy	Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep.
Control	Sleep quality and mood questionnaires	Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep.
Control	Cardiorespiratory monitoring	Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep.
Control	Assessment of cognitive function	Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep.
Main	Sleep quality and mood questionnaires	Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep.

Primary Outcome Measures

Name	Time	Method
White matter hyperintensities volume change	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	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.

Trial Locations

Locations (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University); 🇷🇺 Moscow, Russian Federation