Back to resultsEfficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression
Primary Purpose
Post-stroke Depression
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Depression
Eligibility Criteria
Inclusion Criteria:
- Conforming to the criteria for the diagnosis of PSD recommended by the "Chinese Expert Consensus on Clinical Practice of Post-Stroke Depression";
- Aged 40 to 80 years old;
- The score of HDRS-24 item scale is more than 8 points and less than 35 points, that is, mild to moderate depression;
- Has not received antidepressant treatment or has been discontinued for more than 2 weeks before entering treatment, and has not participated in other ongoing clinical trials.
Exclusion Criteria:
- Subjects with history of mental illness or family history of mental illness;
- Subjects with severe heart, liver, kidney, hematopoietic system, endocrine and immune system diseases;
- Subjects with dementia, aphasia, cognitive dysfunction or unable to cooperate with examination and treatment;
- Subjects installed with the cardiac pacemaker;
- Pregnant or lactating patients.
Sites / Locations
- China Academy of Chinese Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
Participants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks.
Outcomes
Primary Outcome Measures
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％．
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05310175
First Posted
March 25, 2022
Last Updated
September 2, 2023
Sponsor
China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05310175
Brief Title
Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression
Official Title
Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
May 6, 2023 (Actual)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
EA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Other Intervention Name(s)
SA
Intervention Description
Shallow needle insertion of 2-3 mm at sham acupoints without manipulation.
Primary Outcome Measure Information:
Title
The change rate of the total score of Hamilton Depression Rating Scale
Description
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
Secondary Outcome Measure Information:
Title
Changes in the scores of HDRS and its seven kinds of factors
Description
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
Title
Change in the scores of Beck Depression Inventory (BDI)
Description
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
Title
Change in the scores of National Institute of Health stroke scale (NIHSS)
Description
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
Title
Change in the scores of Barthel Index (BI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Conforming to the criteria for the diagnosis of PSD recommended by the "Chinese Expert Consensus on Clinical Practice of Post-Stroke Depression";
Aged 40 to 80 years old;
The score of HDRS-24 item scale is more than 8 points and less than 35 points, that is, mild to moderate depression;
Has not received antidepressant treatment or has been discontinued for more than 2 weeks before entering treatment, and has not participated in other ongoing clinical trials.
Exclusion Criteria:
Subjects with history of mental illness or family history of mental illness;
Subjects with severe heart, liver, kidney, hematopoietic system, endocrine and immune system diseases;
Subjects with dementia, aphasia, cognitive dysfunction or unable to cooperate with examination and treatment;
Subjects installed with the cardiac pacemaker;
Pregnant or lactating patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxiao Zeng
Phone
+86-15901278206
Email
zengyuxiao@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuxiao Zeng
Organizational Affiliation
China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Academy of Chinese Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxiao Zeng
Phone
+86-15901278206
Email
zengyuxiao@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression
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