Post-stroke DepressionNCT05310175
Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression
A study testing Electroacupuncture in people with Post-stroke Depression, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Academy of Chinese Medical Sciences
Beijing
Yuxiao Zeng, +86-15901278206, zengyuxiao@aliyun.com
About this study
Official title: Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Post-stroke Depression
- Being tested
- Electroacupuncture, Sham acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
Also called EA
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.
Sham acupunctureDevice
Also called SA
Shallow needle insertion of 2-3 mm at sham acupoints without manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Device: Electroacupuncture |
| Control group | Placebo comparator | Participants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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％．
Measured: Baseline, week 4
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week4, week16 and week28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start6 May 2022
- Primary completion6 May 2023
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeng Yuxiao, China Academy of Chinese Medical Sciences
- Investigators
- Yuxiao Zeng, Principal investigator, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310175
- Sponsor's protocol ID
- ChinaACMS2022
- Status last verified
- Sep 2023
- First submitted
- 25 Mar 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05310175
- Acronym / sponsor ID
- ChinaACMS2022
- Conditions
- Post-stroke Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: ElectroacupunctureParticipants 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. |
| Control group | Placebo comparator | Device: Sham acupunctureParticipants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAlso: EAFiliform 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. | Device | Experimental group |
| Sham acupunctureAlso: SAShallow needle insertion of 2-3 mm at sham acupoints without manipulation. | Device | Control group |
Primary outcome
The change rate of the total score of Hamilton Depression Rating Scale
Time frame: Baseline, week 4
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％．
4 secondary outcomes
Changes in the scores of HDRS and its seven kinds of factors
Time frame: Baseline, week4, week16 and week28
Change in the scores of Beck Depression Inventory (BDI)
Time frame: Baseline, week4, week16 and week28
Change in the scores of National Institute of Health stroke scale (NIHSS)
Time frame: Baseline, week4, week16 and week28
Change in the scores of Barthel Index (BI)
Time frame: Baseline, week4, week16 and week28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuxiao Zeng principal investigator
China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Post-stroke Depression, run by China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxiao Zeng (+86-15901278206, zengyuxiao@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change rate of the total score of Hamilton Depression Rating Scale (time frame: Baseline, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.