Neural Correlates (EEG and fMRI) of Gait in Small Vessel Disease
ConditionCerebral Small Vessel Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Adults aged 50 years or older attending the Neurology outpatient clinics at Ain Shams University Hospitals, including patients with small vessel disease and gait impairment, and healthy controls.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational
Other interventionno intervention
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Healthy Controls1 intervention
Group B: SVD Patients1 intervention
Trial outcomes
Primary outcomes
1
Functional brain connectivity differences between SVD patients and healthy controls
Differences in resting-state and task-based EEG connectivity and fMRI network activation between patients with cerebral small vessel disease and healthy controls. Connectivity will be analyzed using coherence, phase-locking value (PLV), and correlation matrices derived from resting-state fMRI and EEG. The goal is to identify altered cortico-subcortical communication associated with gait impairment.
Time frame
At baseline (single assessment visit)Secondary outcomes
1
Correlation between imaging findings and clinical gait performance
Evaluate the relationship between EEG/fMRI connectivity parameters and scores on the Timed Up and Go (TUG) test and Berg Balance Scale (BBS) to assess how altered connectivity relates to walking and balance difficulties in SVD.
Time frame
At baseline (single assessment visit)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: