Neural Correlates (EEG and fMRI) of Gait in Small Vessel Disease (doesn't exist)

January 31, 2026 updated by: Hadeer Samir Ahmed Hamada, Ain Shams University

Investigating Neural Correlates of Gait Abnormalities in Patients With Cerebral Small Vessel Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls
Age matched adults with no neurological disorders or gait impairments and normal MRI findings. Participants will undergo the same clinical, EEG, and MRI assessments as the patient group.
Other: No Intervention: Observational
no intervention
SVD Patients
dults aged 50 years or older diagnosed with cerebral small vessel disease (SVD) showing gait disturbance confirmed by MRI (Fazekas score 2-3). Participants will undergo clinical assessment, EEG, and functional MRI.
Other: No Intervention: Observational
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional brain connectivity differences between SVD patients and healthy controls
Time Frame: At baseline (single assessment visit)
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.
At baseline (single assessment visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between imaging findings and clinical gait performance
Time Frame: At baseline (single assessment visit)
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.
At baseline (single assessment visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU132/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The research team will decide after study completion whether de-identified participant data may be shared.

Time Frame To be determined after publication. Access Criteria Requests may be directed to the principal investigator and will require approval by the Faculty of Medicine, Ain Shams University.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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