Electro-acupuncture for SCD With Depression

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of electroacupuncture in treating adults with subjective cognitive decline accompanied by depression. The main objectives are to answer the following questions:

1. Can electroacupuncture improve cognitive function and depressive symptoms in individuals with subjective cognitive decline accompanied by depression?
2. Does electroacupuncture alleviate subjective cognitive decline with depression by modulating the amygdala-entorhinal circuit, and if so, what is the specific mechanism involved? Researchers will compare real electroacupuncture therapy with sham electroacupuncture therapy to determine whether real electroacupuncture can effectively improve symptoms in patients with subjective cognitive decline accompanied by depression. Additionally, multimodal magnetic resonance imaging (MRI) technology will be used to assess changes in the amygdala-entorhinal circuit following electroacupuncture intervention.

Participants will:

1. Receive either real or sham electroacupuncture treatment once daily, 3-5 times per week, for a total treatment duration of 8 weeks.
2. Undergo cognitive function and depression assessments before and after treatment.
3. Complete multimodal cranial magnetic resonance imaging examinations before and after treatment.

Conditions

• Subjective Cognitive Decline (SCD)
• Depression Disorder

Interventions

DEVICE

"TXJN" electro-acupuncture

Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used. The selected acupoints included bilateral Neiguan (PC6), Yintang (EX-HN3), bilateral Yingxiang (LI20), Shenting (GV24), Baihui (GV20), and Sishencong (EX-HN1).After achieving the deqi sensation through acupuncture manipulation, electroacupuncture (SDZ-V, Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.) was applied. The treatment utilized a dense-disperse wave at a frequency of 2 Hz, with a current intensity of 2-4 mA adjusted to the patient's tolerance level. The needles were retained for 30 minutes.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks.

DEVICE

Sham electroacupuncture

Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.Acupoints were selected at 0.2-0.4 cun (5-10 mm) lateral to the original acupoints of the experimental group. The needles were inserted shallowly at a depth of 0.2-0.3 cun (5-8 mm), without eliciting the deqi sensation. The same electroacupuncture device was connected but with no electrical output. The needles were retained for 30 minutes.

Sponsors & Collaborators

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

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2027-01-01

Completion

2027-07-31

Countries

• China

Study Locations