Electro-acupuncture for SCD With Depression

Nanjing University

Status: Active, not recruiting

Conditions: Subjective Cognitive Decline (SCD); Depression Disorder

Treatments: Device: "TXJN" electro-acupuncture; Device: Sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07350226

JSTJ-2024-381

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 60-80 years, right-handed
• Meets the diagnostic criteria for Subjective Cognitive Decline (SCD)
• Geriatric Depression Scale-15 (GDS-15) score ≥5
• Clear consciousness, cooperative during examination, with adequate auditory comprehension
• Patient and family agree to complete assessments and have provided informed consent with signed documentation

Exclusion criteria

• Received other anti-dementia or antidepressant therapy within the past 2 weeks, or currently participating in other clinical trials
• Experienced acute cerebral infarction, cerebral hemorrhage, or transient ischemic symptoms within the past 6 months, or presence of localized old encephalomalacia foci
• History of positive neuropsychiatric disorders and major trauma, including dementia, depression, epilepsy, etc.
• Suffering from other severe comorbidities (aphasia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, diabetic lower limb vascular disease, moderate to severe edema of lower limbs, lower limb venous thrombosis, arteriosclerosis obliterans of lower limbs, peripheral neuropathy, spinal cord lesions, traumatic brain injury, intracranial infection, brain tumors, etc.) or secondary diseases (e.g., heart, liver, or renal failure, etc.)
• Infection at the acupuncture site and/or intolerance to acupuncture therapy
• Contraindications to MRI examination (claustrophobia, surgically implanted metal devices, cochlear implants, implanted pulse generators, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups

Experiment group

Experimental group

Description:

"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.

Treatment:

Device: "TXJN" electro-acupuncture

Control group

Sham Comparator group

Description:

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.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks.

Treatment:

Device: Sham electroacupuncture