Electro-acupuncture for SCD With Depression

NCT07350226 | Active Not Recruiting DMC

• 1 other identifier: JSTJ-2024-381
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can electroacupuncture improve cognitive function and depressive symptoms in individuals with subjective cognitive decline accompanied by depression?
2. 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.
3. 3.Receive either real or sham electroacupuncture treatment once daily, 3-5 times per week, for a total treatment duration of 8 weeks.
4. 4.Undergo cognitive function and depression assessments before and after treatment.
5. 5.Complete multimodal cranial magnetic resonance imaging examinations before and after treatment.

Conditions

Subjective Cognitive Decline (SCD); Depression Disorder

Outcome Measures

Primary Outcomes (3)

• Comprehensive Cognitive Z-Score

  This composite index of global cognitive function is derived from the aggregated Z-scores of eight neuropsychological tests (including Auditory Verbal Learning Test, Animal Fluency Test, Boston Naming Test, Trail Making Test Parts A/B, Stroop Color-Word Test-Card C, Digit Symbol Substitution Test, Digit Span Test, and Clock Drawing Test). At baseline, each test's raw scores will be standardized using the study population's mean and standard deviation (Z = \[raw score - mean\]/SD). For tests where lower scores indicate better performance (e.g., Trail Making Test time), Z-scores are reversed (multiplied by -1) to align directionality. The final aggregated Z-score, expressed in standard deviation units, will be assessed pre-treatment and 8 weeks post-treatment initiation.

  Before and 8 weeks after treatment

• Geriatric Depression Scale 15-Item (GDS-15) Reduction Rate

  The reduction rate is calculated based on the total score (range: 0-15, where a higher score indicates more severe depressive symptoms) of the 15-item Geriatric Depression Scale. The reduction rate formula is: (\[Pre-treatment score - Post-treatment score\] / Pre-treatment score) × 100%. Efficacy is defined as: Markedly Effective (reduction rate ≥ 50%); Effective (50% \> reduction rate ≥ 25%); Ineffective (reduction rate \< 25%).

  Before and 8 weeks after treatment

• Multimodal magnetic resonance imaging indicators

  sMRI indicators: GMV, FA, MD; rs-fMRI indicators: ALFF, fALFF, ReHo, Seed-based FC.

  Before and 8 weeks after treatment

Secondary Outcomes (12)

• Mini-Mental State Examination (MMSE) Total Score

  Before and 8 weeks after treatment

• Auditory Verbal Learning Test (AVLT) Long-Delay Free Recall Score

  Before and 8 weeks after treatment

• Rey-Osterrieth Complex Figure Test (ROCF) Delayed Recall Score

  Before and 8 weeks after treatment

• Boston Naming Test (BNT) Total Correct Score

  Before and 8 weeks after treatment

• Animal Fluency Test (AFT) Total Score

  Before and 8 weeks after treatment

Other Outcomes (2)

• Treatment Acceptance Survey Response

  After 8 weeks of treatment

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From treatment initiation up to 8 weeks.

Study Arms (2)

Experiment group

EXPERIMENTAL

"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: "TXJN" electro-acupuncture

Control group

SHAM COMPARATOR

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.

Device: Sham electroacupuncture

Interventions

Sham electroacupuncture DEVICE

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.

Control group

"TXJN" electro-acupuncture DEVICE

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.

Experiment group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

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 11, 2025
• First Posted: January 20, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)