Clinical trial NCT04569643: Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease.
Official title: Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease: a Clinical and Neuropsychological Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodic Limb Movement Disorder
Cerebral Small Vessel Diseases
Cognitive Dysfunction
Keywords: Aged
Cerebral Small Vessel Disease
Cognitive Dysfunction
Magnetic Resonance Imaging
Periodic Limb Movement Disorder
Sleep Disorder
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

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).


Eligibility criteria: 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.

Primary outcomes:
measure: White matter hyperintensities volume change
timeFrame: 1 year
measure: Degree of Cognitive Decline
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Ekaterina D. Spektor, M.D.
role: PRINCIPAL_INVESTIGATOR
References: