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

• ClinicalTrials.gov Identifier: NCT04569643
• Recruitment Status: Enrolling by invitation
• First Posted: September 30, 2020
• Last Update Posted: February 21, 2021
• Sponsor: I.M. Sechenov First Moscow State Medical University
• Information provided by (Responsible Party): I.M. Sechenov First Moscow State Medical University

Study Description

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).

Condition or disease	Intervention/treatment
Periodic Limb Movement Disorder; Cerebral Small Vessel Diseases; Cognitive Dysfunction	Diagnostic Test: Actigraphy; Diagnostic Test: Cardiorespiratory monitoring; Diagnostic Test: Neuroimaging; Other: Assessment of cognitive function; Other: Sleep quality and mood questionnaires

Study Design

• Study Type: Observational
• Estimated Enrollment: 76 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease: a Clinical and Neuropsychological Study.
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: August 31, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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.
Control; Patients with cerebral small vessel disease and periodic limb movement index less than 15 movements per hour of sleep.	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.

Outcome Measures

Primary Outcome Measures :

1. White matter hyperintensities volume change [ Time Frame: 1 year ]
   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.
2. Degree of Cognitive Decline [ Time Frame: 1 year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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).

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.

Contacts and Locations

Locations

Russian Federation

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

Moscow, Russian Federation

Sponsors and Collaborators

I.M. Sechenov First Moscow State Medical University

Investigators

• Principal Investigator: Ekaterina D. Spektor, M.D.; I.M. Sechenov First Moscow State Medical University (Sechenov University)

More Information

• Responsible Party: I.M. Sechenov First Moscow State Medical University
• ClinicalTrials.gov Identifier: NCT04569643
• Other Study ID Numbers: 2207
• First Posted: September 30, 2020
• Last Update Posted: February 21, 2021
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by I.M. Sechenov First Moscow State Medical University:

Aged; Cerebral Small Vessel Disease; Cognitive Dysfunction; Magnetic Resonance Imaging; Periodic Limb Movement Disorder; Sleep Disorder

Additional relevant MeSH terms:

Movement Disorders; Cerebral Small Vessel Diseases; Nocturnal Myoclonus Syndrome; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias