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Construction and promotion of a digital therapy + TCM brain health intervention platform: A prospective, multicenter, double-blind, double-dummy, randomized controlled trial of electroacupuncture combined with cognitive digital therapy for mild cognitive impairment

Construction and promotion of a digital therapy + TCM brain health intervention platform: A prospective, multicenter, double-blind, double-dummy, randomized controlled trial of electroacupuncture combined with cognitive digital therapy for mild cognitive impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002596
Enrollment
Unknown
Registered
2025-12-30
Start date
2025-08-25
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

mild cognitive impairment

Interventions

The electro-acupuncture combined with cognitive digital therapy treatment group:Electroacupuncture combined with cognitive digital therapy
Electroacupuncture treatment group:Electroacupuncture combined with limited cognitive digital therapy
Cognitive Digital Therapy Treatment Group:Cognitive digital therapy combined with sham acupuncture
Placebo control group:Fake acupuncture combined with limited cognitive digital therapy
Healthy group:No intervention measures

Sponsors

Medicine affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the above-mentioned diagnostic criteria for MCI (2) Age ranging from 40 to 80 years old (3) Reports from patients or caregivers of a persistent decline in memory or other cognitive domains for at least 3 months (4) A score of =20 on the Mini-Mental State Examination (MMSE) for those with primary school education or a score of =24 for those with junior high school education or above, and a score of =26 on the Montreal Cognitive Assessment (MoCA) (5) At least 6 years of education (6) Normal or mild activities of daily living (7) Patients who have not received acupuncture treatment (8) Voluntary signing of the informed consent form

Exclusion criteria

Exclusion criteria: (1) Diagnosed with any type of dementia (2) Individuals with severe mental disorders and neurodevelopmental delays (3) Suffering from other neurological diseases that may cause brain function impairment (such as epilepsy, intracranial tumors, Parkinson's disease, metabolic disorders, encephalitis, multiple sclerosis, brain trauma, normal pressure hydrocephalus, etc.) (4) Cognitive impairment caused by other systemic diseases: such as liver dysfunction, kidney dysfunction, thyroid dysfunction, severe anemia, folic acid and vitamin B12 deficiency, CO poisoning, special infections (such as syphilis, AIDS), alcohol and drug abuse, etc. (5) Patients with contraindications for magnetic resonance scanning (with cochlear implants, implanted electrodes, cardiac pacemakers or metal implants, etc.) (6) Severe kidney or liver diseases, cancer or severe diseases; (7) Within 1 month, have taken anti-dementia treatment drugs (such as cholinesterase inhibitors, aspartate receptor antagonists, etc.) and anti-vascular cognitive impairment drugs (8) Unable to receive acupuncture treatment or cooperate in completing digital therapy.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment,MOCA;

Secondary

MeasureTime frame
Mini-Mental State Examination,MMSE;Auditory Word Learning Test - Huashan Version, AWLT-H;Boston Naming Test, BNT;Health Survey Short Form,SF-36;Patient Health Questionnaire 9 items, PHQ-9;Multimodal magnetic resonance scanning;Trail Making Test Part B (TMT-B);Plasma biochemical indicators;

Countries

China

Contacts

Public ContactXin Wang

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

xinflare827@126.com15652608247

Outcome results

None listed

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