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

NCT05310175 | Unknown

• 1 other identifier: ChinaACMS2022
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Depression

Outcome Measures

Primary Outcomes (1)

• 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％．

  Baseline, week 4

Secondary Outcomes (4)

• Changes in the scores of HDRS and its seven kinds of factors

  Baseline, week4, week16 and week28

• Change in the scores of Beck Depression Inventory (BDI)

  Baseline, week4, week16 and week28

• Change in the scores of National Institute of Health stroke scale (NIHSS)

  Baseline, week4, week16 and week28

• Change in the scores of Barthel Index (BI)

  Baseline, week4, week16 and week28

Study Arms (2)

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.

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.

Device: Sham acupuncture

Interventions

Electroacupuncture 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.

Also known as: EA

Experimental group

Sham acupuncture DEVICE

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

Also known as: SA

Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (1)

China Academy of Chinese Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Yuxiao Zeng

  China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuxiao Zeng

CONTACT

+86-15901278206; zengyuxiao@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral candidate of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: May 6, 2022
• Primary Completion: May 6, 2023
• Study Completion: October 1, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)