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

I.M. Sechenov First Moscow State Medical University

Status

Unknown

Conditions

Periodic Limb Movement Disorder

Cerebral Small Vessel Diseases

Cognitive Dysfunction

Treatments

Diagnostic Test: Neuroimaging

Other: Assessment of cognitive function

Diagnostic Test: Cardiorespiratory monitoring

Other: Sleep quality and mood questionnaires

Diagnostic Test: Actigraphy

Study type

Observational

Funder types

Other

Identifiers

NCT04569643

2207

Details and patient eligibility

About

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).

Enrollment

76 estimated patients

Sex

All

Ages

60 to 75 years old

Volunteers

No Healthy Volunteers

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.