Neural Correlates (EEG and fMRI) of Gait in Small Vessel Disease

NCT07372937 | Not Yet Recruiting DMC

• 1 other identifier: FMASU132/2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Small Vessel Disease

Keywords

Gait Disturbances, Vascular cognitive impairment; gait disturbances; vascular cognitive impairment

Outcome Measures

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.

  At baseline (single assessment visit)

Secondary Outcomes (1)

• Correlation between imaging findings and clinical gait performance

  At baseline (single assessment visit)

Study Arms (2)

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

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

Interventions

No Intervention: Observational OTHER

no intervention

Healthy Controls; SVD Patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11566, Egypt

Location

Related Publications (5)

• 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 RESULT

• Su C, Yang X, Wei S, Zhao R. Association of cerebral small vessel disease with gait and balance disorders. Front Aging Neurosci. 2022;14:834496. PMID: 35528672

  RESULT

• 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 RESULT

• 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 Medicine. 2021;19(1):234. PMID: 34521428

  RESULT

• 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 RESULT

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hadeer Samir, Msc Neurology

CONTACT

+201011035548; Hadeer.samir@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of neurology, MD candidate , Ain Shams University

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

EG (1)