NCT04569643

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

Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease: a Clinical and Neuropsychological Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 76 (estimated)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Periodic Limb Movement Disorder
• Cerebral Small Vessel Diseases
• Cognitive Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Actigraphy	Participants will undergo overnight leg actigraphy at baseline. Leg movements will be recorded bilaterally by actigraphic method with two ankle-worn recorders.
DIAGNOSTIC_TEST	Cardiorespiratory monitoring	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.
DIAGNOSTIC_TEST	Neuroimaging	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.
OTHER	Assessment of cognitive function	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.
OTHER	Sleep quality and mood questionnaires	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-04-30
• Completion: 2022-08-31
• First posted: 2020-09-30
• Last updated: 2021-02-21

Locations

1 site across 1 country: Russia