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

NCT ID: NCT04569643

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-08-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Main

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

Actigraphy

Intervention Type: DIAGNOSTIC_TEST

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

Cardiorespiratory monitoring

Intervention Type: 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.

Neuroimaging

Intervention Type: 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.

Assessment of cognitive function

Intervention Type: 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.

Sleep quality and mood questionnaires

Intervention Type: 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

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

Actigraphy

Intervention Type: DIAGNOSTIC_TEST

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

Cardiorespiratory monitoring

Intervention Type: 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.

Neuroimaging

Intervention Type: 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.

Assessment of cognitive function

Intervention Type: 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.

Sleep quality and mood questionnaires

Intervention Type: 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.

Interventions

Actigraphy

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekaterina D. Spektor, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

2207

Identifier Type: -

Identifier Source: org_study_id