Can Acupuncture Treat Post-stroke Depression?

NCT02644161 | Completed

• 1 other identifier: UW 15-421
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

stroke; depression; stroke sequelae; acupuncture; DCEAS; CAI; LAS

Outcome Measures

Primary Outcomes (5)

• Changes in depression measured by HAMD-17

  Depression will be measured using the Hamilton Rating Scale for Depression (HAMD-17). Assessments will be conducted at baseline and once monthly thereafter.

  Baseline, 4 week, 8 week

• Changes in depression measured by MADRS

  Depression will be measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). Assessments will be conducted at baseline and once monthly thereafter.

  Baseline, 4 week, 8 week

• Changes in depression measured by SDS

  Depression will be measured using the Zung Self-Rating Depression Scale (SDS). Assessments will be conducted at baseline and once monthly thereafter.

  Baseline, 4 week, 8 week

• Changes in locomotor function measured by BI

  Locomotor function will be measured using the Barthel Index of Activities of Daily Living (BI). Assessments will be conducted at baseline and once monthly thereafter.

  Baseline, 4 week, 8 week

• Changes in cognitive function

  The Montreal Cognitive Assessment (MoCA) will be used as an objective measurement for subjects' cognitive function. Assessments will be conducted at baseline and once monthly thereafter.

  Baseline, 4 week, 8 week

Secondary Outcomes (3)

• Clinical outcome of treatment

  8 week

• Emergence of adverse events

  Baseline, 4 week, 8 week

• TCM syndrome diagnosis

  Baseline

Study Arms (2)

Combination acupuncture treatment (CAI)

ACTIVE COMPARATOR

Post stroke depression patients will receive Dense Cranial Electroacupuncture Stimulation (DCEAS) and body acupuncture. Patients will continue their existing antidepressant and rehabilitation therapy as usual.

Procedure: Dense cranial electroacupuncture stimulation; Procedure: Body acupuncture; Drug: Antidepressant; Other: Rehabilitation

Least acupuncture stimulation (LAS)

SHAM COMPARATOR

Post stroke depression patients will receive Least acupuncture stimulation (LAS). Patients will continue their existing antidepressant and rehabilitation therapy as usual.

Drug: Antidepressant; Other: Rehabilitation; Procedure: Least acupuncture stimulation

Interventions

Dense cranial electroacupuncture stimulation PROCEDURE

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).

Also known as: DCEAS

Combination acupuncture treatment (CAI)

Body acupuncture PROCEDURE

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.

Also known as: BA

Combination acupuncture treatment (CAI)

Antidepressant DRUG

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

Combination acupuncture treatment (CAI); Least acupuncture stimulation (LAS)

Rehabilitation OTHER

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

Also known as: Rehab

Combination acupuncture treatment (CAI); Least acupuncture stimulation (LAS)

Least acupuncture stimulation PROCEDURE

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.

Also known as: LAS

Least acupuncture stimulation (LAS)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men or women aged 35 to 80 years old;
• diagnosed as ischemic or haemorrhagic stroke within 18 months, confirmed with cerebral computed topographic scanning or magnetic resonance imaging; and
• developed significant depressive episode, with score of 16 or greater in the 17-item Hamilton Rating Scale for Depression (HAMD-17) and depression has lasted at least 2 weeks.

You may not qualify if:

• presence of severe aphasia, especially fluent aphasia;
• presence of severe cognitive dysfunction, as indicated by the Mini-mental State Examination (MMSE) score \< 18;
• history of psychiatric illness other than depression;
• presence of another chronic disorder, including severe Parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism;
• having impaired hepatic or renal function; or (6) having bleeding tendency.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Tung Wah Hospital: collaborator
• Kowloon Hospital, Hong Kong: collaborator

Study Sites (2)

Department of Rehabilitation, Kowloon Hospital

Kowloon, Hong Kong

Location

Division of Rehabilitation Medicine, Tung Wah Hospital.

Sheung Wan, Hong Kong

Location

Related Publications (26)

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MeSH Terms

Conditions

Stroke; Depression

Interventions

Antidepressive Agents; Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Zhang-Jin ZHANG, MMed, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 31, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)