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

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

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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University

  lead OTHER

Principal Investigators

• Ekaterina D. Spektor, M.D. · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2022-04-30

Completion

2022-08-31

Countries

• Russia

Study Locations