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Mechanism of neural network remodeling in precise intervention of vascular and neurodegenerative diseases by tFUS based on individual targets: a randomized, double-blind, controlled clinical trial

Mechanism of neural network remodeling in precise intervention of vascular and neurodegenerative diseases by tFUS based on individual targets: a randomized, double-blind, controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098182
Enrollment
Unknown
Registered
2025-03-04
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Vascular and neurodegenerative diseases

Interventions

The normal control group with true stimulation:tFUS was used to accurately intervene brain regions
Patients with vascular dementia with true stimulation:tFUS was used to accurately intervene brain regions
Patients with Alzheimers disease with true stimulation:tFUS was used to accurately intervene brain regions
The normal control group with sham stimulation:Sham tFUS was used to accurately intervene brain regions
Patients with vascular dementia with sham stimulation:Sham tFUS was used to accurately intervene brain regions
Patients with Alzheimers disease with sham stimulation:Sham tFUS was used to accurately intervene brain regions

Sponsors

Nanjing Drum Tower Hospital of The Affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Vascular dementia patients: vascular dementia caused by small vessel disease, neuropsychological examination confirmed that the cognitive function is significantly reduced, mainly manifested in memory impairment, orientation, attention, language function, spatial function, executive function, motor control and other functional deficits, with significant decline in social function. The presence of cerebral small vessel disease was examined, and imaging studies proved that the clinical symptoms were due to cerebral small vessel disease. Dementia occurs within 3 to 6 months after cerebrovascular disease. (2) Alzheimer's disease patients: The diagnostic criteria for Alzheimer's disease was the diagnostic criteria proposed by the 2018 Chinese Guidelines for the diagnosis and Treatment of Dementia and cognitive impairment, that is, the cognitive impairment reported by the patient or an informant, or found by an experienced clinician; Objective evidence of impairment in one or more cognitive domains measured on cognitive tests, with cognitive level 1-2 standard deviations below the average of a normal population matched for age, sex, and education. The diagnosis of Alzheimer's disease was confirmed by cerebrospinal fluid, PET-CT, or other relevant evidence. (3) Healthy control group: subjects had no obvious complaints of nervous system related discomfort, such as headache, dizziness, limb weakness and other subjective and objective cognitive dysfunction. For those with junior high school education or above, Mini-mental state examination (MMSE) >= 24 points, Montreal Cognitive Assessment (MoCA) score >= 26; For those with primary school education, MMSE >= 20, MoCA >= 24; Activities of daily living were normal, and the Activity of daily living (ADL) scale was within the normal range matched for age and education.

Exclusion criteria

Exclusion criteria: (1) Patients with hemorrhagic or ischemic acute vascular events in the past three months; (2) patients with mental disorders or drug-induced cognitive impairment. (3) History of severe anxiety, depression, schizophrenia and other mental disorders. (4) cognitive dysfunction caused by central nervous system trauma, alcohol abuse, tumor, metabolic disease, hypothyroidism, infection and other reasons. (5) patients who used antipsychotic drugs or improved cognitive impairment in the past two weeks. (6) There were contraindications such as epilepsy, pacemaker implantation, and cochlear implantation

Design outcomes

Primary

MeasureTime frame
Change in episodic memory function ;

Secondary

MeasureTime frame
Changes in Executive Function;Changes in language function;Changes in Information processing function;

Countries

China

Contacts

Public ContactYun Xu

Nanjing Drum Tower Hospital of The Affiliated Hospital of Nanjing University Medical School

xuyun20042001@aliyun.com+86 139 1476 4479

Outcome results

None listed

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