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

NCT04569643 | Unknown DMC

• 1 other identifier: 2207
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• White matter hyperintensities volume change

  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.

  1 year

• Degree of Cognitive Decline

  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.

  1 year

Study Arms (2)

Main

Patients with cerebral small vessel disease and periodic limb movement index equal or more than 15 movements per hour of sleep.

Diagnostic Test: Actigraphy; Diagnostic Test: Cardiorespiratory monitoring; Diagnostic Test: Neuroimaging; Other: Assessment of cognitive function; Other: Sleep quality and mood questionnaires

Control

Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep.

Diagnostic Test: Actigraphy; Diagnostic Test: Cardiorespiratory monitoring; Diagnostic Test: Neuroimaging; Other: Assessment of cognitive function; Other: Sleep quality and mood questionnaires

Interventions

Actigraphy DIAGNOSTIC_TEST

Participants will undergo overnight leg actigraphy at baseline. Leg movements will be recorded bilaterally by actigraphic method with two ankle-worn recorders.

Control; Main

Cardiorespiratory monitoring DIAGNOSTIC_TEST

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.

Control; Main

Neuroimaging DIAGNOSTIC_TEST

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.

Control; Main

Assessment of cognitive function OTHER

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.

Control; Main

Sleep quality and mood questionnaires OTHER

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.

Control; Main

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location

MeSH Terms

Conditions

Nocturnal Myoclonus Syndrome; Cerebral Small Vessel Diseases; Cognitive Dysfunction; Sleep Wake Disorders

Interventions

Actigraphy; Neuroimaging

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Parasomnias; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques; Diagnostic Imaging; Diagnostic Techniques, Neurological

Study Officials

• Ekaterina D. Spektor, M.D.

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: December 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: August 31, 2022
• Last Updated: February 21, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)