Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression

NCT ID: NCT05310175

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-06

Study Completion Date

2024-10-31

Brief Summary

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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

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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

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Post-stroke Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type DEVICE

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.

Control group

Participants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks.

Group Type PLACEBO_COMPARATOR

Sham acupuncture

Intervention Type DEVICE

Shallow needle insertion of 2-3 mm at sham acupoints without manipulation.

Interventions

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Electroacupuncture

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

Sham acupuncture

Shallow needle insertion of 2-3 mm at sham acupoints without manipulation.

Intervention Type DEVICE

Other Intervention Names

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EA SA

Eligibility Criteria

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Inclusion Criteria

1. Conforming to the criteria for the diagnosis of PSD recommended by the "Chinese Expert Consensus on Clinical Practice of Post-Stroke Depression";
2. Aged 40 to 80 years old;
3. The score of HDRS-24 item scale is more than 8 points and less than 35 points, that is, mild to moderate depression;
4. 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

1. Subjects with history of mental illness or family history of mental illness;
2. Subjects with severe heart, liver, kidney, hematopoietic system, endocrine and immune system diseases;
3. Subjects with dementia, aphasia, cognitive dysfunction or unable to cooperate with examination and treatment;
4. Subjects installed with the cardiac pacemaker;
5. Pregnant or lactating patients.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zeng Yuxiao

Doctoral candidate of China Academy of Chinese Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuxiao Zeng

Role: PRINCIPAL_INVESTIGATOR

China Academy of Chinese Medical Sciences

Locations

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China Academy of Chinese Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuxiao Zeng

Role: CONTACT

+86-15901278206

Facility Contacts

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Yuxiao Zeng

Role: primary

+86-15901278206

Other Identifiers

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ChinaACMS2022

Identifier Type: -

Identifier Source: org_study_id

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