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A Study on the Brain Functional Mechanism and Intervention of Gait Disorders and Cognitive Impairment in Patients with Cerebral Small Vessel Disease

A Study on the Brain Functional Mechanism and Intervention of Gait Disorders and Cognitive Impairment in Patients with Cerebral Small Vessel Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109705
Enrollment
Unknown
Registered
2025-09-24
Start date
2023-04-18
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral small vessel disease

Interventions

TMS+Drug therapy group:Transcranial magnetic stimulation (twice a day for 7 days, a total of 14 sessions, with stimulation at 40% intensity, inter-burst frequency of 37Hz, and inter-burst frequency of
Drug therapy group: Medication treatment according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Cerebral Small Vessel Disease 2021" and based on individual circumstances, includi
Healthy control group:None

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Cerebral Small Vessel Disease (CSVD) Patient Group: (1) Meets the diagnostic criteria for CSVD according to the 2022 CSVD Guidelines; exhibits clinical manifestations of CSVD (e.g., cognitive impairment, gait disturbance, mood disorders, or urinary/bowel dysfunction), has relevant vascular risk factors, and shows one or more MRI features characteristic of CSVD; (2) Aged 18–85 years; (3) Able to cooperate with functional near-infrared spectroscopy (fNIRS) assessment and gait analysis walking tasks; (4) Modified Rankin Scale (mRS) score <= 3; (5) Provided written informed consent. 2. Healthy Control Group: (1) Healthy individuals without cerebral small vessel disease; (2) Aged 18–85 years; (3) Able to cooperate with relevant clinical scales, fNIRS assessment, and gait analysis walking tasks; (4) Provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with cerebral small vessel disease: (1) Acute phase of cerebral infarction caused by large-artery atherosclerosis, cardioembolism, cryptogenic sources, or other rare etiologies; (2) History of neurological disorders such as epilepsy, multiple sclerosis, Parkinson’s disease, or Alzheimer’s disease; (3) Psychiatric disorders such as schizophrenia or inability to cooperate with the study tasks; (4) History of traumatic brain injury, brain surgery, intracerebral hemorrhage, or severe systemic medical conditions; (5) Contraindications preventing completion of MRI examination; 2. Healthy control group: (1) Acute phase of cerebral infarction caused by large-artery atherosclerosis, cardioembolism, cryptogenic sources, or other rare etiologies; (2) History of neurological disorders such as epilepsy, multiple sclerosis, Parkinson’s disease, or Alzheimer’s disease; (3) Psychiatric disorders such as schizophrenia or inability to cooperate with the study tasks; (4) History of traumatic brain injury, brain surgery, intracerebral hemorrhage, or severe systemic medical conditions; (5) Contraindications preventing completion of MRI examination.

Design outcomes

Secondary

MeasureTime frame
Functional near-infrared spectroscooy data;Eye tracking instrument data;

Primary

MeasureTime frame
Head MRI data;3-Meter Timed Up and Go Test;Gait status;Overall cognitive status;Emotional state;Assesses reaction speed and executive function.;Executive function;Attention;Language function;Visuospatial function, executive function, and writing ability;Visuospatial function;Urinary continence status;Activities of Daily Living ;Gait instrument data;

Countries

China

Contacts

Public ContactZhang Bingwei

The First Affiliated Hospital of Dalian Medical University

zhangbingweidoc@163.com+86 180 9887 6286

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026