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The"Yi Sui Xing Shen"Traditional Chinese Medicine Comprehensive Rehabilitation Protocol in the treatment of Cerebral Key Area Infarction Combined with Cognitive Impairment:A multicenter randomized double-blind study

Research on the multimodal brain mechanisms and application of the"Yi Sui Xing Shen"Traditional Chinese Medicine Comprehensive Rehabilitation Protocol in treating post-stroke cognitive impairment in critical areas

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078391
Enrollment
Unknown
Registered
2023-12-07
Start date
2023-12-08
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Cerebral Key Area Infarction Combined with Cognitive Impairment

Interventions

Treatment Groups:"Yi Sui Xing Shen" acupuncture, cognitive rehabilitation training, and conventional western medical treatment,An 8-week intervention will be conducted
Control Groups:"Non-meridian and non-acupoint" acupuncture , cognitive rehabilitation training and conventional Western medical treatments,An 8-week intervention will be conducted

Sponsors

Dongzhimen Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Experienced one or more clearly traceable acute cerebrovascular events (ischemic) within 14-28 days prior to enrollment, diagnosed by CT or MRI as infarction in the frontal, temporal, or parietal lobes; (2) Self-reported or family-reported cognitive decline occurring after the stroke event, confirmed by clinical assessment by a neurologist or traditional Chinese medicine specialist, and further confirmed by a neurocognitive assessment scale to not meet the criteria for dementia, but with at least one cognitive domain impaired, including attention/executive function, memory, language, and visuospatial function. Daily life abilities may be normal or mildly impaired, but this impairment should be unrelated to motor/sensory symptoms caused by the stroke event. (3) No restriction on ethnicity, aged between 18 and 80 years. Individuals with significant speech expression difficulties should have a caregiver or family member who can provide support for more than 4 days a week. (4) Cognitive Neurology Psychological Assessment Scale: Clinical Dementia Rating (CDR) score of 0.5 or less in one cognitive domain and a total score of =0.5; Montreal Cognitive Assessment Beijing Version (MoCA) score <26, but =20; (5) Functional Independence Measure (FIM) total score =72, with a cognitive capacity score of =20; (6) NIH Stroke Scale (NIHSS) score =3 and =20; Hachinski Ischemic Scale (HIS) score =7; (7) Signed informed consent in accordance with ethical requirements.

Exclusion criteria

Exclusion criteria: (1) Diagnosis of any known cognitive impairment before the onset of the stroke event, including alcohol-induced cognitive impairment, and so on; (2) Symptoms or conditions that may affect neurocognitive assessment, such as severe aphasia, uncontrollable active mental illness, or post-stroke physical disabilities that impact psychological assessment; (3) Pre-experimental research found that the neurocognitive scores of stroke patients in critical brain regions were significantly incompatible with Inclusion Criterion 5 (CDR>0.5 or MoCA<20), thus excluding patients with cognitive impairment caused by critical brain region strokes, with critical brain regions defined as the thalamus, frontal lobe, hippocampus, etc.; (4) Exclusion of stroke patients with severe cardiorespiratory dysfunction, liver or kidney insufficiency, unstable vital signs, and exclusion of patients with severe lung infections, urinary tract infections, pressure ulcers, or other conditions that may affect follow-up; (5) Severe Vascular Cognitive Impairment (major VCI or VaD): Significant cognitive impairment exists in at least one cognitive domain (cognitive impairment can exist in multiple domains), and its severity affects the independence of daily life, while also excluding daily life impairments caused by vascular events' sensory/motor deficits (independently of post-event motor/sensory sequelae). There is a clear temporal relationship between cerebrovascular events or vascular brain damage (pathological/imaging) and the onset of cognitive impairment; (6) Severe hearing and visual impairments, with shallow sensory abnormalities in the neurological examination; (7) Non-consent to participate in the study or refusal to sign the informed consent form; (8) Poor patient or family cooperation and other patients considered unable to complete the observation period.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Test(MoCA);

Secondary

MeasureTime frame
Brain Derived Neurotrophic Factor(BDNF);Short Chain Fatty Acid(SCFAs);Urinary Nerve Growth Factor(NGF);Mini-mental State Examination(MMSE);Clinical Dementia Rating(CDR);

Countries

China

Contacts

Public ContactChang Jingling

Dongzhimen Hospital of Beijing University of Chinese Medicine

ear6979@163.com+86 186 1118 1701

Outcome results

None listed

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