Can Acupuncture Treat Post-stroke Depression?

Summary

An 8-week, assessor-blind, randomized controlled trial will be conducted. A total of 138 patients with post-stroke depression (PSD) will be randomly assigned to the combination acupuncture treatment (CAI) (n = 69) or least acupuncture stimulation (LAS) (n = 69) for 3 sessions per week for 8 weeks. Treatment outcomes will be measured using the 17-item Hamilton Self-Rating Depression Scale (HAMD-17), the Montgomery-Asberg Depression Rating Scale (MADRS), and Self-Rating Depression Scale (SDS) for depression symptoms; Barthel Index (BI) for physical function, the Montreal Cognitive Assessment (MoCA) for cognitive performance. The assessment will be performed at baseline and once monthly thereafter. The study will be conducted in School of Chinese Medicine Clinics, Tung Wah Hospital, Kowloon Hospital.

Conditions

• Stroke
• Depression
• Stroke Sequelae

Interventions

PROCEDURE

Dense cranial electroacupuncture stimulation

DCEAS is a novel stimulation mode in which electrical stimulation is delivered on acupoints located on the forehead. Six pairs of acupoints are used: Baihui (GV20, +) and Yintang (EX-HN3, -), left Sishencong (EX-HN1, -) and Toulinqi (GB15, +), right Sishencong (EX-HN1, -) and Toulinqi (GB15, +), bilateral Shuaigu (GB8, L+, R-), bilateral Taiyang (EX-HN5, L+, R-), and bilateral Touwei (ST8, L+, R-). Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation, followed by electrical stimulation (ITO ES-160, continuous waves at 2 Hz, 100 µs).

PROCEDURE

Body acupuncture

Following acupoints are used: Shui-Gou (GV26), Shen-Men (HT7). He-Gu (LI4), Qu-Chi (LI11), Guan-Yuan (CV4), Zu-San-Li (ST36), Feng-Long (ST40) and San-Yin-Jiao (SP6). Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation at 15 min. No electrical stimulation is delivered.

DRUG

Antidepressant

Patients will continue their existing antidepressant therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.

OTHER

Rehabilitation

Patients will continue their existing rehabilitation therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.

PROCEDURE

Least acupuncture stimulation

The acupoints chosen are less related to the treated syndromes based on Traditional Chinese Medicine (TCM) theory; the number of acupoints used and the intensity of electrical stimulation are also lower than the comprehensive acupuncture regimen. The following 6 acupoints will be used in LAS control: bilateral Tong-Tian (BI7, L+, R-), bilateral Shou San-Li (LI10) and bilateral Fu-Yang (BL59). Electrical stimulation will be only performed on bilateral Tong-Tian (BI7) and the intensities are adjusted to a level at which patients just start feeling the stimulation.

Sponsors & Collaborators

• Tung Wah Hospital

  collaborator OTHER

• Kowloon Hospital, Hong Kong

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Zhang-Jin ZHANG, MMed, PhD · School of Chinese Medicine, The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2018-07-31

Completion

2018-10-31

Countries

• Hong Kong

Study Locations