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

Cognitive Dysfunction Clinical Trial

Official title:

Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease: a Clinical and Neuropsychological Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04569643
• Other study ID #: 2207
• Status: Enrolling by invitation
• Start date: December 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2020
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 76
• Est. completion date: August 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Cognitive Dysfunction
• Movement Disorders
• Nocturnal Myoclonus Syndrome
• Periodic Limb Movement Disorder

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Russian Federation	I.M. Sechenov First Moscow State Medical University (Sechenov University)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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