Neural Correlates (EEG and fMRI) of Gait in Small Vessel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention: Observational.
- Who it may be relevant to
- Registry conditions: Cerebral Small Vessel Disease. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating Neural Correlates of Gait Abnormalities in Patients With Cerebral Small Vessel Disease
Overview
What is the purpose of this study? This observational study is being done to understand how cerebral small vessel disease (SVD) affects walking and balance. SVD is a common brain condition in older adults that damages small blood vessels. It can lead to problems with movement, thinking, and memory. The researchers want to find out how changes in brain activity and connectivity contribute to walking difficulties in people with SVD. Why is this study important? Walking and balance problems increase the risk of falls and loss of independence. By studying brain activity during walking-related tasks, researchers hope to identify patterns that explain why these problems happen. This knowledge could help develop better rehabilitation methods in the future. Who can participate? Adults over 50 years old with cerebral small vessel disease and gradual gait problems may be eligible. Healthy adults of similar age without neurological problems may also take part as control participants. What will happen in this study? Participants will: Complete walking, balance, and cognitive tests such as the Timed Up and Go, Berg Balance Scale, and Montreal Cognitive Assessment. Undergo brain imaging (MRI) to confirm the diagnosis and study brain structure and function. Have an EEG recording while resting and while watching short videos showing walking and turning movements. A smaller group will also undergo functional MRI (fMRI) while watching the same videos. The MRI and EEG results will be analyzed to see how brain networks involved in movement and balance differ between patients and healthy adults. How long will the study take? The study will take about two years to complete. Each participant's visit will last approximately two to three hours in total. What are the possible benefits? There may be no direct benefit to participants. However, this study may help researchers understand how small vessel disease affects brain function related to walking, which may improve care for future patients.
Detailed description
Cerebral small vessel disease (SVD) is a common cause of walking and balance problems in older adults. These problems are often not explained by muscle weakness alone. They are believed to result from changes in how different parts of the brain communicate and coordinate movement.
This study will explore how brain network function is affected in people with SVD who experience gait difficulties. To do this, two safe and non-invasive techniques will be used:
Functional MRI (fMRI): to identify which brain areas become active when participants watch videos that simulate walking and turning.
Electroencephalography (EEG): to measure brain waves and the timing of brain activity while watching the same gait-related videos.
Participants will include 20 patients diagnosed with cerebral small vessel disease and gait problems, and 20 healthy adults of similar age without such problems.
All participants will undergo:
1. Clinical evaluation including walking, balance, and cognitive tests (Timed Up and Go, Berg Balance Scale, and Montreal Cognitive Assessment). 2. Brain MRI to confirm the diagnosis and exclude other causes. 3. Resting and task-based EEG recordings to assess brain connectivity. 4. Functional MRI for a subset of participants to study brain activity patterns related to gait imagery.
Researchers will compare the brain activation and connectivity between patients and healthy participants. They will also look for relationships between imaging findings and clinical test results.
By combining fMRI and EEG findings, this research aims to identify brain networks that are disrupted in people with SVD-related gait problems. Understanding these patterns may lead to better tools for early detection and more targeted rehabilitation approaches to improve walking and prevent falls.
All study procedures will be conducted at the Neurology Department, Ain Shams University Hospitals, Cairo, Egypt.
Interventions
- Other No Intervention: Observational
no intervention
Primary outcome measures
- Functional brain connectivity differences between SVD patients and healthy controls [Time frame: At baseline (single assessment visit)]
Secondary outcome measures (1)
- Correlation between imaging findings and clinical gait performance [Time frame: At baseline (single assessment visit)]
Eligibility criteria
Inclusion criteria
- Age 50 years or older.
- Clinical and radiological diagnosis of cerebral small vessel disease (SVD), confirmed by MRI findings such as white matter hyperintensities, lacunes, or microbleeds.
- Fazekas score 2 or 3 on MRI.
- Presence of slowly progressive gait disturbance (e.g., slowness, imbalance, freezing) rather than acute stroke presentation.
- Ability to give informed consent and cooperate with testing procedures.
Exclusion criteria
- Presence of other neurodegenerative disorders (e.g., Parkinson's disease, Alzheimer's disease).
- History of large vessel stroke or intracerebral hemorrhage.
- Contraindications to MRI (e.g., pacemaker, metallic implants, severe claustrophobia).
- Severe cognitive impairment that prevents participation (MoCA <10).
- Musculoskeletal or orthopedic causes of gait disturbance not related to neurological dysfunction.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Egypt · 1 center
- Ain Shams University Hospitals — Cairo
Publications
- Torres-Simon L, Doval S, Nebreda A, Llinas SJ, Marsh EB, Maestu F. Understanding brain function in vascular cognitive impairment and dementia with EEG and MEG: A systematic review. Neuroimage Clin. 2022;35:103040. doi: 10.1016/j.nicl.2022.103040. Epub 2022 May 10. PMID 35653914
- Su C, Yang X, Wei S, Zhao R. Association of Cerebral Small Vessel Disease With Gait and Balance Disorders. Front Aging Neurosci. 2022 Jul 8;14:834496. doi: 10.3389/fnagi.2022.834496. eCollection 2022. PMID 35875801
- Mele G, Cavaliere C, Alfano V, Orsini M, Salvatore M, Aiello M. Simultaneous EEG-fMRI for Functional Neurological Assessment. Front Neurol. 2019 Aug 13;10:848. doi: 10.3389/fneur.2019.00848. eCollection 2019. PMID 31456735
- Schulz M, Malherbe C, Cheng B, Thomalla G, Schlemm E. Functional connectivity changes in cerebral small vessel disease - a systematic review of the resting-state MRI literature. BMC Med. 2021 May 5;19(1):103. doi: 10.1186/s12916-021-01962-1. PMID 33947394
- Sharma B, Wang M, McCreary CR, Camicioli R, Smith EE. Gait and falls in cerebral small vessel disease: a systematic review and meta-analysis. Age Ageing. 2023 Mar 1;52(3):afad011. doi: 10.1093/ageing/afad011. PMID 37000039
Identifiers
NCT: NCT07372937 · FMASU132/2025