An interventional study of Electroacupuncture and Sham acupuncture in Post-stroke Depression, sponsored by China Academy of Chinese Medical Sciences. Recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
The objective of this trial is to evaluate the efficacy and safety of electroacupuncture at acupoints group around the base of skull for post-stroke depression.
98 eligible participants with post-stroke depression will be recruited and randomly assigned to the experimental group and the control group in a ratio of 1:1. Participants in both groups will receive electroacupuncture or placebo acupuncture treatment at acupoints group around the base of skull 3 times a week for 4 weeks, and followed up for 24 weeks.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 98 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Participants will receive electroacupuncture at Yamen(DU15), bilateral Tianzhu(BL10), Fengchi(GB20), Wangu(GB12), and Yifeng(SJ17) for 30minutes, 3 times a week for 4 weeks.
Device: Electroacupuncture
Participants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks.
Device: Sham acupuncture
Filiform needles (0.30×50mm, Hanyi brand, Beijing Medical Appliance, China) and the SDZ-V electric acupuncture (Suzhou Medical Appliance) apparatus will be used. After acupuncture at the acupoints group, the needle handle will be connected with the electrode of the electric acupuncture apparatus.
Also known as: EA
Shallow needle insertion of 2-3 mm at sham acupoints without manipulation.
Also known as: SA
The change rate of the total score of Hamilton Depression Rating Scale
The therapeutic effects are assessed based upon HDRS score-reducing rate． Cure: HDRS score-reducing rate≥75％; Remarkable effect: HDRS score-reducing rate≥50％, \<75％; Improvement: HDRS score-reducing rate≥25％, \<50％; Failure: HDRS score-reducing rate\<25％．
Time frame: Baseline, week 4
Changes in the scores of HDRS and its seven kinds of factors
The change in total score of HDRS and changes in its seven kinds of factors at the end of week4, 16 and 28, compared with baseline. The HDRS-24 has two scoring methods: total scores and seven-category factor scores. A total score of 78 points, with higher scores indicating more severe depression: a score below 8 indicates no depression; a score of 8-20 indicates mild depression; a score of 20-35 indicates moderate depression; and a score of more than 35 indicates major depression. Seven types of factors are anxiety/somatization, weight, cognitive impairment, day and night changes, retardation, sleep disturbance, and sense of hopelessness. The scores of each category of factors could reflect in which aspect the patients' specific depressive symptoms showed.
Time frame: Baseline, week4, week16 and week28
Change in the scores of Beck Depression Inventory (BDI)
The change in total score of BDI at the end of week4, 16 and 28, compared with baseline. The BDI scale has a total score of 63 points, with higher scores indicating more severe depression: A score of 1 to 10 points suggests normal, a score of 11 to 16 points suggests mild emotional disturbance, a score of 17 to 20 points suggests clinically borderline depression, a score of 21 to 30 points suggests moderate depression, and a score of ≥ 31 points suggests severe depression.
Time frame: Baseline, week4, week16 and week28
Change in the scores of National Institute of Health stroke scale (NIHSS)
The change in total score of NIHSS at the end of week4, 16 and 28, compared with baseline. The NIHSS mainly evaluates the neurological deficit of stroke patients, which includes 15 items such as cognition, language, sensory, motor, visual field deficit, etc. The total score is 42 points. The higher the score, the more serious the neurological deficit. A score of 0 to 1 indicates normal or nearly normal, a score of 1 to 4 indicates a mild stroke, a score of 5 to 15 indicates a moderate stroke, and a score of \> 20 indicates a severe stroke.
Time frame: Baseline, week4, week16 and week28
Change in the scores of Barthel Index (BI)
The change in total score of BI at the end of week4, 16 and 28, compared with baseline. The BI scale consists of 10 items that evaluate eating, bathing, daily washing, dressing, urinating, toileting, walking, activity and going up stairs, respectively. The total score of 100 points is classified as normal. A higher score indicates better independence and quality of survival of the patient.
Time frame: Baseline, week4, week16 and week28
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in May 2023, 12 months.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
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China Academy of Chinese Medical Sciences