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The clinical research of monitoring the effects of acupuncture in vascular cognitive impairment by Calibrated fMRI

The clinical research of monitoring the effects of acupuncture in vascular cognitive impairment by Calibrated fMRI

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076595
Enrollment
Unknown
Registered
2023-10-12
Start date
2023-08-06
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Vascular Cognitive Impairment

Interventions

True acupuncture group:Subjects were required to receive 12 true acupuncture interventions within one and a half months.
Non-acupoint group:The non-meridian and non-acupoint parts near the acupoints in the true acupuncture group were selected for 12 times of shallow acupuncture.
Drug group:Within a month and a half to ' Aricept ' treatment, oral 1 pill a day.
Control Group:None

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients group: ( 1 ) Right-handed, age 50-85 years old, gender unlimited ; ( 2 ) Education level above primary school ( including primary school ) ; ( 3 ) Cognitive impairment is time-related to cerebrovascular events, or there is no cerebrovascular event, but the information processing speed and complex attention / frontal executive function are significantly impaired ; ( 4 ) According to the imaging diagnostic criteria of vascular cognitive impairment caused by cerebral small vessel disease ( VASCOG ), there were subcortical ischemic cerebrovascular lesions caused by cerebral small vessel disease in MRI and / or CT, including subcortical small infarction, high signal in white matter, vascular lacuna, perivascular space, microbleeds and brain atrophy ; ( 5 ) Neuropsychological scale assessment : MoCA score was between 10 and 26 points ; the total score of modified Hachinski ischemic scale ( MHIS ) was > 7, and the score of clinical dementia rating scale ( CDR ) was 0.5. ( 6 ) No contraindication of MRI scan; ( 7 ) Definite diagnosis of hypertension. Control group: (1) Right-handed, age range 50-85 years old, regardless of gender; (2) Normal cognitive function: MoCA score>26 points, Clinical Dementia Rating (CDF) score of 0, no history of mental illness such as depression; (5) I have not received any vascular dementia drugs, related physical therapy, or acupuncture treatment within the past month; (6) No life-threatening systemic diseases; (7) No contraindications for magnetic resonance imaging examination; (8) Understand the progress of this study and agree to sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patients group: ( 1 ) Previous memory or other cognitive dysfunction, but there is no obvious ischemic lesion on the image ; ( 2 ) Cognitive dysfunction caused by trauma, tumor, infection, thyroid dysfunction, alcoholism, etc. ; ( 3 ) Severe visual acuity, hearing impairment and aphasia, affecting the examination or can not cooperate with the completion of the scale assessment, or can not keep still during MR scan ; ( 4 ) With depression, mental disorders and disturbance of consciousness ; ( 5 ) Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases ( such as unstable angina, uncontrolled asthma, active gastric bleeding, etc. ) and cancer ; ( 6 ) Have a history of traumatic brain injury or cerebral hemorrhage, massive cerebral infarction in the past 1 month ; ( 7 ) There are contraindications for MR examination ; ( 8 ) Received acupuncture treatment in the past 4 weeks ; ( 9 ) Can not complete the basic course of treatment, compliance may be poor ( that is, can not adhere to the treatment ) and difficult to follow up in the future.

Design outcomes

Primary

MeasureTime frame
Montreal cognitive assessment scale;Blood Oxygenation Level Dependent Imaging in Magnetic resonance imaging;Diffusion Tensor Imaging in Magnetic resonance imaging;Blood pressure variability;

Secondary

MeasureTime frame
Quantitative susceptibility mapping in Magnetic resonance imaging;Arterial Spin Labeling in Magnetic resonance imaging;MMSE, SDS, PSQI;Blood related indicators, including hypersensitive C-reactive protein (hs CRP), interleukin-6 (IL-6), serum ferritin, etc;

Countries

China

Contacts

Public ContactWenli Tan

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

tanying2245@163.com+86 21 2025 6561

Outcome results

None listed

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