Clinical trial NCT06758154: Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline: A Multicenter Randomized Controlled Trial and fMRI Study
Official title: Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline: A Multicenter Randomized Controlled Trial and fMRI Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline (SCD)
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 92
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria for SCD diseases;
2. 55-79 years old;
3. ≥8 years of schooling;
4. Right-handed;
5. Sign the informed consent.

Exclusion Criteria:

1. Have received other antidepressant therapy or involved in other clinical trials in the previous 2weeks.
2. Infarct located in the left DLPFC.
3. Positive psychiatric history and major trauma exposure history, such as depression, epilepsy, etc., in the past.
4. Other serious concomitant diseases (aphasia, severe edema, venous thrombosis, arteriosclerosis occlusion, diabetic vascular disease, peripheral neuropathy, spinal lesions, brain trauma, intracranial infection, brain tumors, etc.) or secondary diseases (heart, liver, renal failure, etc.).
5. Infection around acupoints and/or intolerance to acupuncture manipulation.
6. MRI or rTMS contraindications (claustrophobia, metal implants, cochlear implants, impulsator, etc.).

Primary outcomes:
measure: Comprehensive Z score
timeFrame: Before and 8 weeks after treatment
measure: Multimodal magnetic resonance imaging of olfactory related neural circuits
timeFrame: Before and 8 weeks after treatment
Secondary outcomes:
measure: mini-mental state examination, MMSE
timeFrame: Before and 8 weeks after treatment
measure: Montreal Cognitive Assessment,MoCA
timeFrame: Before and 8 weeks after treatment
measure: Subjective cognitive self-scoring
timeFrame: Before and 8 weeks after treatment
measure: Hamilton Depression Scale，HAMD
timeFrame: Before and 8 weeks after treatment
measure: the Geriatric Depression Scale,GDS
timeFrame: Before and 8 weeks after treatment
measure: Hamilton Anxiety Scale,HAMA
timeFrame: Before and 8 weeks after treatment
measure: auditory verbal learning test,AVLT
timeFrame: Before and 8 weeks after treatment
measure: Rey complex figure test,CFT
timeFrame: Before and 8 weeks after treatment
measure: Boston naming test,BNT
timeFrame: Before and 8 weeks after treatment
measure: Animal fluency test,AFT
timeFrame: Before and 8 weeks after treatment
measure: rail making test-A,TMT-A
timeFrame: Before and 8 weeks after treatment
measure: rail making test-B,TMT-B
timeFrame: Before and 8 weeks after treatment
measure: complex figure test, CFT
timeFrame: Before and 8 weeks after treatment
measure: clock drawing test,CDT
timeFrame: Before and 8 weeks after treatment
measure: Symbol Digit Modalities Test,SDMT
timeFrame: Before and 8 weeks after treatment
measure: odor threshold test,OTT
timeFrame: Before and 8 weeks after treatment
measure: The olfactory behavioral test
timeFrame: Before and 8 weeks after treatment
measure: Spatial navigation behavior test
timeFrame: Before and 8 weeks after treatment
measure: Pittsburgh sleep quality index,PSQI
timeFrame: Before and 8 weeks after treatment
measure: TCM physique classification scale
timeFrame: Before and 8 weeks after treatment
measure: TCM syndrome type scale of mild cognitive impairment
timeFrame: Before and 8 weeks after treatment
Other outcomes:
measure: Acceptance survey
timeFrame: After 8 weeks of treatment
measure: Adverse event
timeFrame: During treatment
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References: