Cerebral Small Vessel Diseasedoesn't existNCT07372937
Neural Correlates (EEG and fMRI) of Gait in Small Vessel Disease
An observational study of Cerebral Small Vessel Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Disease
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University Hospitals
Cairo, Cairo Governorate, 11566
Hadeer Samir, 01011035548, hadirsamir462@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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:
- Clinical evaluation including walking, balance, and cognitive tests (Timed Up and Go, Berg Balance Scale, and Montreal Cognitive Assessment).
- Brain MRI to confirm the diagnosis and exclude other causes.
- Resting and task-based EEG recordings to assess brain connectivity.
- 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.
- Conditions
- Cerebral Small Vessel Disease
- Being tested
- No Intervention: Observational
- Keywords
- Gait Disturbances, Vascular cognitive impairment, gait disturbances, vascular cognitive impairment
- Medical subject headings
- Cerebral Small Vessel Diseases, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: ObservationalOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention: Observational | |
| 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. Receives: Other: No Intervention: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (single assessment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Samir Ahmed Hamada, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372937
- Sponsor's protocol ID
- FMASU132/2025
- Acronym
- doesn't exist
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 35653914Su 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.
PubMed 35875801Mele 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.
PubMed 31456735Schulz 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.
PubMed 33947394Sharma 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.
PubMed 37000039