An interventional study of "TXJN" electro-acupuncture and sham acupuncture in Subjective Cognitive Decline (SCD), sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to participants aged 55 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Treatment
Subjective cognitive decline (SCD) is the early diagnosis and treatment window period of Alzheimer's disease (AD), and the identification of SCD individuals who will progress to AD (pSCD) is a research hotspot. Based on olfactory fMRI,previous studies have found that SCD individuals showed damaged entorhinal neural circuits. After follow-up, the incidence of pSCD increased by three times. But,the spatiotemporal characteristics of the entorhinal neural circuits and whether it has the value of individualized prediction and intervention target need to be further studied. Thus, based on multi-center ambispective cohort study at home and abroad, we will (1) build a new paradigm of synchronous fMRI-EEG olfactory task state Oddball experiment, jointly representational similarity analysis, extract spatiotemporal characteristics of neural circuits damage, and discover and verify that the entorhinal neural circuits are vulnerable brain regions; (2) establish the middle fusion model of vulnerable brain region combined with the methods of olfactory task-fMRI activation image generation, functional connectome gradient,etc.; Then, establish late fusion multi-omics multi-task model combined with the new methods of molecularomics such as ultra-deep total proteomics and metabonomics proposed by the research group to accurately identify pSCD; (3) carry out the precise intervention of image-guided "olfactory three-needle" acupuncture with the entorhinal neural circuits as the target. Through clinical RCT research and mouse model, the remodeling mechanism of vulnerable brain regions will be clarified.This project will provide the basis for early diagnosis and treatment of the AD risk population.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
True electroacupuncture
Device: "TXJN" electro-acupuncture
Sham electroacupuncture
Device: sham acupuncture
Firstly, EA treatment will be administered at the Neiguan (PC6, bilateral), Shenting(GV23), Yingxiang(LI20, bilateral), Yintang(GV29) acupoints. Disposable stainless-steel needles (0.25 mm × 25 mm; Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Suzhou City, China) will be used. After skin disinfection, the acupuncturists will twist and thrust the needle handles to achieve the sensations of achiness, heaviness, and numbness (known as de qi) at all above-mentioned acupoints. Following needle manipulations, EA instruments (SDZ-V, Hwato brand, Suzhou Medical Supplies Factory Co., Ltd., Suzhou City, China) will be used to attach the needle handles at PC6, GV23, LI20, GV29, with a dilatational wave of 5 Hz and a current intensity of 2 \~ 4 mA depending on the patient's tolerance. The needles will be removed after 30 min. Participants will receive 24 sessions over 8 weeks at a frequency of 3 times per week.
Firstly, EA treatment will be administered at the non-acupoints near above-mentioned real acupoints. Disposable stainless-steel needles (0.25 mm × 25 mm; Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Suzhou City, China) will be used. After skin disinfection, the acupuncturists will take the needle into the acupoints without the sensations of de qi. Following needle manipulations, EA instruments (SDZ-V, Hwato brand, Suzhou Medical Supplies Factory Co., Ltd., Suzhou City, China) will be used to attach the needle handles at non-acupoints without the current. The needles will be removed after 30 min. Participants will receive 24 sessions over 8 weeks at a frequency of 3 times per week.
Comprehensive Z score
The neuropsychological scale of 8 objective cognitive assessments used in the study (including AVLT (S and L), AFT, BNT, TMT (A and B), SCWT-C, DSST, DST, CDT) was converted into Z scores for description. Specific operations: Standardize the score of a single cognitive domain scale, create the corresponding Z-score data set, calculate the average value of each data in the group to generate a single Z-score, and sum the Z-score of each single cognitive domain to generate the overall Z-score. Patients were evaluated before treatment and 8 weeks later.
Time frame: Before and 8 weeks after treatment
Multimodal magnetic resonance imaging of olfactory related neural circuits
Structural MRI(3DTIWI/3DT2WI/3Dflair), functional MRI(BOLD\\NODDI\\ASL\\ QSM)
Time frame: Before and 8 weeks after treatment
mini-mental state examination, MMSE
Time frame: Before and 8 weeks after treatment
Montreal Cognitive Assessment,MoCA
Time frame: Before and 8 weeks after treatment
Subjective cognitive self-scoring
Time frame: Before and 8 weeks after treatment
Hamilton Depression Scale，HAMD
Time frame: Before and 8 weeks after treatment
the Geriatric Depression Scale,GDS
Time frame: Before and 8 weeks after treatment
Hamilton Anxiety Scale,HAMA
Time frame: Before and 8 weeks after treatment
auditory verbal learning test,AVLT
Time frame: Before and 8 weeks after treatment
Rey complex figure test,CFT
Time frame: Before and 8 weeks after treatment
Boston naming test,BNT
Time frame: Before and 8 weeks after treatment
Animal fluency test,AFT
Time frame: Before and 8 weeks after treatment
rail making test-A,TMT-A
Time frame: Before and 8 weeks after treatment
rail making test-B,TMT-B
Time frame: Before and 8 weeks after treatment
complex figure test, CFT
Time frame: Before and 8 weeks after treatment
clock drawing test,CDT
Time frame: Before and 8 weeks after treatment
Symbol Digit Modalities Test,SDMT
Time frame: Before and 8 weeks after treatment
odor threshold test,OTT
Time frame: Before and 8 weeks after treatment
The olfactory behavioral test
Time frame: Before and 8 weeks after treatment
Spatial navigation behavior test
Time frame: Before and 8 weeks after treatment
Pittsburgh sleep quality index,PSQI
Time frame: Before and 8 weeks after treatment
TCM physique classification scale
Time frame: Before and 8 weeks after treatment
TCM syndrome type scale of mild cognitive impairment
Time frame: Before and 8 weeks after treatment
Acceptance survey
Time frame: After 8 weeks of treatment
Adverse event
Time frame: During treatment
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School