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The efficacy of theta burst precuneus stimulation on cognition decline in patients with mild vascular cognitive impairments

The efficacy of theta burst precuneus stimulation on cognition decline in patients with mild vascular cognitive impairments

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096351
Enrollment
Unknown
Registered
2025-01-22
Start date
2025-01-27
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Mild vascular cognitive impairment

Interventions

rTMS true stimulation + cognitive rehabilitation training group:All subjects in the rTMS True Stimulation + Cognitive Rehabilitation Training group were treated with the intermittent mode (iTBS) of TB
rTMS pseudo-stimulation + cognitive rehabilitation training group:All subjects in the rTMS sham stimulation + cognitive rehabilitation training group received sham rTMS stimulation, that is, the coil

Sponsors

Shanghai Geriatric Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age>=45 years old, =80 points. 2. Diagnosed with cerebral small vessel disease, and the cranial MRI image within 1 year meets the 2023 international STRIVE-2 standard: a) Presumed vascular-derived cavities: subcortical round or oval cavities filled with cerebrospinal fluid, typically 3-15 mm in diameter. A Fazekas scale score of >=2 is required; b) White matter hyperintensity: hyperintensity of bilateral cerebral hemisphere symmetry on magnetic resonance T2-weighted images. A Fazekas scale score of >=2 is required; c) Cerebral microhemorrhage: magnetic resonance T2-weighted images or hypointense lesions with a diameter of 2-5mm on a magnetically sensitive sequence. Requiring >=5 microbleeding foci; d) Iron deposition on the surface of the cerebral cortex: linear hypointensity on the surface of the cerebral cortex on magnetic resonance T2 gradient echoes or other blood-sensitive sequences; 3. There is no clear history of stroke in the past, and there is no sequelae of focal neurological impairment. 4. Cognitive decline reported by the patient or observed by the clinician in the case of confirmed cerebral small vessel disease, but the cognitive impairment is not sufficient to significantly interfere with functional independence. MMSE scale > = 18 points, ADL scale > = 80 points are required. 5. Able to cooperate with the completion of neuropsychological tests, the overall cognitive function scale score decreases (below the cut-off score, or significantly decreases compared with the pre-onset level) or at least two cognitive domain scale scores in the full set of neuropsychological tests (2 standard deviations below the reference value in healthy people, or significantly decreased compared with the pre-onset level). 6. Although there may be subtle difficulties in complex functional tasks, cognitive impairment is not sufficient to significantly interfere with functional independence. MMSE scale > = 18 points, ADL scale > = 80 points are required. 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Meet the diagnostic criteria of dementia; 2.Precuneus lesions; 3.The intracranial lesions have been diagnosed as demyelinating diseases, white matter dystrophy, intracranial space occupying lesions, autoimmune encephalitis, etc. 4.Cognitive impairment can be explained by other causes, such as Alzheimer's disease, frontotemporal dementia, dementia with lewy bodies, delirium, acute cerebral infarction, acute cerebral hemorrhage, major depression, chronic alcoholism, metabolic disorders, adverse drug reactions or brain trauma. 5.Complications such as severe anxiety, depression, excessive daytime sleepiness, mental disorders, etc., can not cooperate with cognitive function tests. 6.Combined with lower extremity fracture, joint deformity, etc., can not cooperate with gait test. 7.Combined with hearing allergy, uncontrolled hypertension, recent heart disease, severe cardiopulmonary insufficiency, malignant tumor, pregnancy, etc. 8.There are contraindications related to rTMS. a) Concomitant history of epilepsy; b) There are metal implants in the body, such as pacemakers, deep brain electrodes, vagus nerve stimulators, cochlear implants, metal stents for intracranial blood vessels, mechanical valves, etc.

Design outcomes

Primary

MeasureTime frame
Change in MoCA scale score after 6 months of Precuneus rTMS stimulation/pseudo-stimulation;

Secondary

MeasureTime frame
Change in mean cerebral blood flow velocity after 6 months of Precuneus rTMS stimulation/pseudo-stimulation;Changes in the latent period and amplitude of P300 after 6 months of Precuneus rTMS stimulation/pseudo-stimulation.;Changes in other cognition scale scores after 6 months of Precuneus rTMS stimulation/pseudo-stimulation;Change in gait speed after 6 months of Precuneus rTMS stimulation/pseudo-stimulation.;

Countries

China

Contacts

Public ContactWeifeng Peng

Shanghai Geriatric Medical Center

peng.weifeng@zs-hospital.sh.cn+86 21 51371990

Outcome results

None listed

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