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

China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Post-stroke Depression

Treatments: Device: Sham acupuncture; Device: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05310175

ChinaACMS2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

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.

Treatment:

Device: Electroacupuncture

Control group

Placebo Comparator group

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.

Treatment:

Device: Sham acupuncture