Efficacy and Olfactory Network of Electro-acupuncture for Subjective Cognitive Decline: A Multicenter Randomized Controlled Trial and fMRI Study

Nanjing University

Status: Active, not recruiting

Conditions: Subjective Cognitive Decline (SCD)

Treatments: Device: sham acupuncture; Device: "TXJN" electro-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06758154

2024-050-01

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

Experimental group

Experimental group

Treatment:

Device: "TXJN" electro-acupuncture

Control group

Sham Comparator group

Treatment:

Device: sham acupuncture