Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination (MMSE) Total Score | The total score (range: 0-30) of the Mini-Mental State Examination, where a higher score indicates better cognitive function. | Before and 8 weeks after treatment |
| Auditory Verbal Learning Test (AVLT) Long-Delay Free Recall Score |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Acceptance Survey Response | The participant's response to a single-item Treatment Acceptance Survey at the end of the treatment period. Responses are categorized as: "Completely Acceptable", "Acceptable", or "Not Acceptable". | After 8 weeks of treatment |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
The score for the long-delay free recall trial of the Auditory Verbal Learning Test (range: 0-15 words), where a higher score indicates better episodic memory function. |
| Before and 8 weeks after treatment |
| Rey-Osterrieth Complex Figure Test (ROCF) Delayed Recall Score | The score for the delayed recall trial of the Rey-Osterrieth Complex Figure Test, which is typically scored on a standardized system (e.g., 0-36 points based on accuracy and placement of reproduced elements), where a higher score indicates better visual-spatial memory and recall ability. | Before and 8 weeks after treatment |
| Boston Naming Test (BNT) Total Correct Score | The total number of correctly named items (range: 0-30) of the 30-item Boston Naming Test, where a higher score indicates better confrontational word retrieval and language ability. | Before and 8 weeks after treatment |
| Animal Fluency Test (AFT) Total Score | The total number of correct, unique animal names generated within 60 seconds (common score range: 0-50+), where a higher score indicates better semantic verbal fluency and executive functioning. | Before and 8 weeks after treatment |
| Trail Making Test Part A (TMT-A) Completion Time | The time to completion (in seconds) for Trail Making Test Part A, where a shorter completion time indicates better visual attention, processing speed, and motor function. | Before and 8 weeks after treatment |
| Trail Making Test Part B (TMT-B) Completion Time | The time to completion (in seconds) for Trail Making Test Part B, where a shorter completion time indicates better cognitive flexibility, task-switching ability, and executive function. | Before and 8 weeks after treatment |
| Clock Drawing Test (CDT) Total Score | The total score on the standardized 30-point Clock Drawing Test (CDT30-AJ/CI version, range: 0-30), where a higher score indicates better visuospatial/executive function and cognitive integrity. | Before and 8 weeks after treatment |
| Symbol Digit Modalities Test (SDMT) Correct Response Count | The total number of correct symbol-digit pairings completed within 90 seconds (common score range: 0-110+), where a higher score indicates better processing speed, sustained attention, and visual scanning. | Before and 8 weeks after treatment |
| Pittsburgh Sleep Quality Index (PSQI) Global Score | The global score (range: 0-21) of the Pittsburgh Sleep Quality Index, where a higher score indicates poorer sleep quality. | Before and 8 weeks after treatment |
| TCM Constitution Classification and Determination Scale - Transformed Scores | The transformed scores (range: 0-100 for each of the nine constitution subscales) calculated according to the standardized "TCM Constitution Classification and Determination Scale" (published by the China Association of Chinese Medicine). A higher transformed score on a specific subscale indicates a more pronounced tendency towards that constitution type (e.g., Yang Deficiency, Qi Deficiency, etc.). | Before and 8 weeks after treatment |
| TCM Syndrome Type Scale for Mild Cognitive Impairment Subscale Scores | Scores (range: 0-30 per syndrome) for seven TCM syndrome types (e.g., Spleen-Kidney Deficiency) as assessed by the standardized "TCM Syndrome Type Scale for Mild Cognitive Impairment", where a higher score indicates more severe syndrome manifestation. | Before and 8 weeks after treatment |
The number and proportion of participants experiencing any treatment-emergent adverse event(s), classified by system organ class and severity (e.g., mild, moderate, severe), according to a standardized dictionary (e.g., MedDRA) and assessed for relationship to the study treatment. |
| From treatment initiation up to 8 weeks. |