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

NCT06758154 | Active Not Recruiting DMC

• 1 other identifier: 2024-050-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Cognitive Decline (SCD)

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  Before and 8 weeks after treatment

Secondary Outcomes (21)

• mini-mental state examination, MMSE

  Before and 8 weeks after treatment

• Montreal Cognitive Assessment,MoCA

  Before and 8 weeks after treatment

• Subjective cognitive self-scoring

  Before and 8 weeks after treatment

• Hamilton Depression Scale，HAMD

  Before and 8 weeks after treatment

• the Geriatric Depression Scale,GDS

  Before and 8 weeks after treatment

Other Outcomes (2)

• Acceptance survey

  After 8 weeks of treatment

• Adverse event

  During treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

Device: "TXJN" electro-acupuncture

Control group

SHAM COMPARATOR

Device: sham acupuncture

Interventions

"TXJN" electro-acupuncture DEVICE

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.

Experimental group

sham acupuncture DEVICE

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.

Control group

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for SCD diseases;
• years old;
• ≥8 years of schooling;
• Right-handed;
• Sign the informed consent.

You may not qualify if:

• Have received other antidepressant therapy or involved in other clinical trials in the previous 2weeks.
• Infarct located in the left DLPFC.
• Positive psychiatric history and major trauma exposure history, such as depression, epilepsy, etc., in the past.
• 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.).
• Infection around acupoints and/or intolerance to acupuncture manipulation.
• MRI or rTMS contraindications (claustrophobia, metal implants, cochlear implants, impulsator, etc.).

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 3, 2025
• Study Start: April 6, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 3, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)