Can Acupuncture Treat Post-stroke Depression? (PSD2)
Primary Purpose
Stroke, Depression, Stroke Sequelae
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Dense cranial electroacupuncture stimulation
Body acupuncture
Antidepressant
Rehabilitation
Least acupuncture stimulation
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, depression, stroke sequelae, acupuncture, DCEAS, CAI, LAS
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Rehabilitation, Kowloon Hospital
- Division of Rehabilitation Medicine, Tung Wah Hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Combination acupuncture treatment (CAI)
Least acupuncture stimulation (LAS)
Arm Description
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.
Post stroke depression patients will receive Least acupuncture stimulation (LAS). Patients will continue their existing antidepressant and rehabilitation therapy as usual.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Clinical outcome of treatment
It includes clinical response, defined as <50% reduction at endpoint from baseline on HAMD-17, and remission, defined as 7 points or less on HAMD-17 score.
Emergence of adverse events
Adverse events are assessed using the Treatment Emergent Symptom Scale (TESS).
TCM syndrome diagnosis
To determine Traditional Chinese Medicine (TCM) syndrome correlated of the treatment efficacy, the investigators will conduct TCM syndrome diagnosis. The 5 most common syndromes of PSD are listed below:
Liver Depression with Qi-stagnation;
Liver Depression with Spleen deficiency;
Blood stasis and phlegm obstruction;
Deficiency of Both Heart and Spleen; or
Deficiency of Both Liver and Kidney Yin.
Full Information
NCT ID
NCT02644161
First Posted
December 18, 2015
Last Updated
May 17, 2019
Sponsor
The University of Hong Kong
Collaborators
Tung Wah Hospital, Kowloon Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02644161
Brief Title
Can Acupuncture Treat Post-stroke Depression?
Acronym
PSD2
Official Title
A Multisite, Assessor-blinded, Randomized Controlled Trial of Acupuncture for Post-stroke Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Tung Wah Hospital, Kowloon Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Mood depression is a common and serious consequence of stroke (Paolucci, 2008). There are approximately 30% of stroke patients developing PSD, either in the early or in the late stages after stroke (Paolucci, 2008). Despite the fact that PSD is strongly associated with the poor prognosis and an increased disability, it is often neglected in the clinical management, with only a minority of PSD patients who could receive proper diagnoses and treatment (Gustafson et al., 1995; Paolucci, 2008; Williams et al., 2004). Although pharmacological treatment, represented by various types of antidepressants, are recommended as first-line drugs for PSD, the effectiveness is unsatisfactory and the clinical use is largely hampered due to apparent shortcomings. A large portion of PSD patients could not obtain satisfactory outcomes from antidepressant treatment, in particular the elderly (Bhogal et al., 2005;Paolucci, 2008). Pharmacotherapy related side effects; particularly on cardiovascular system may exacerbate stroke patients' conditions (Paolucci, 2008). Furthermore, stroke patients are often medicated with various classes of drugs, the addition of antidepressant agents may increase risk of drug-drug interactions, resulting in unexpected and unpredictable adverse events (Hemeryck and Belpaire, 2002). The development of alternative treatment strategies for PSD patients is therefore highly desired.
While acupuncture is effective in reducing pain disorders, it also possesses psychotropic potential in treating psychiatric symptoms, in particular depression, anxiety and sleep disturbance. Our systematic review with meta-analysis suggests that the clinical outcomes of acupuncture is equivalent to antidepressant in treating major depression and superior to pharmacotherapy in improving clinical response and reducing the severity of PSD, with fewer incidences of adverse events (Zhang et al., 2010). Recently, the investigators have developed a novel acupuncture stimulation mode called dense cranial electroacupuncture stimulation (DCEAS), in which electrical stimulation is directly delivered on dense acupoints (6-8 pairs in general) located on the forehead innervated by the trigeminal sensory pathway. This pathway has intimate afferent fibers projecting the brainstem reticular formation, a pivotal brain region containing serotonin (5-HT) and norepinephrine (NE) neuronal cells involved in the processing of mood signals. neuroanatomic rationale for DCEAS is that electrical stimulation on dense scalp acupoints could enhance the activities of brainstem nuclei containing 5-HT and NE neuronal systems via the trigeminal sensory nucleus, and then modulate brain regions related to mood processing (Zhang et al., 2012).Our serial clinical studies have demonstrated the effectiveness of DCEAS and alike modes in patients with major depression, postpartum depression, insomnia and obsessive compulsive disorder (Chung et al., 2012; 2014; Huang et al., 2004, 2005; Qu et al., 2013; Zhang et al., 2009, 2012a). Most recently, our pilot study further confirms that DCEAS is effective in reducing stroke patients' depressive symptoms; a combination of DCEAS and body acupuncture (CAI) is more effective in reducing neuropsychiatric sequelae of stroke (Man et al., 2014). These encouraging results warrant a large-scale controlled trial.
The pathogenesis of PSD is mainly associated with decreased serotonin (5-HT) and norepinephrine (NE) function in the brain (Gustafson et al., 1995). On the other hand, neuro-anatomic rationale for DCEAS is that electrical stimulation on dense scalp acupoints could enhance the activities of brainstem nuclei containing 5-HT and NE neuronal systems via the trigeminal sensory nucleus, and then modulate brain regions related to mood processing (Zhang et al., 2012b). Based on these studies, the investigators hypothesize that CAI could yield better treatment outcomes in improving PSD compared to Least acupuncture stimulation (LAS) control.
An apparent advantage of TCM clinical practice is individualized or personalized treatment, i.e., treatment protocol is tailored to meet individual's current clinical manifestations and different stages of illness, termed differentiation syndromes. Previous studies have suggested a potential relationship between the therapeutic efficacy of acupuncture and TCM syndromes of PSD (Dang, 2013; Wu, 2010; Xin et al., 2005). The investigators will further determine whether there are correlates of TCM syndromes of PSD with the CAI treatment.
The working hypothesis of the proposed study is that CAI is an effective intervention in improving PSD and comorbid symptoms often observed in stroke patients. To test this hypothesis, an 8-week, assessor-blind, randomized, controlled trial will be proposed to determine: (1) whether the patients treated with the CAI could produce significantly greater improvement than those treated with LAS and (2) whether there are correlates of TCM syndromes of PSD with the CAI treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression, Stroke Sequelae
Keywords
stroke, depression, stroke sequelae, acupuncture, DCEAS, CAI, LAS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination acupuncture treatment (CAI)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Least acupuncture stimulation (LAS)
Arm Type
Sham Comparator
Arm Description
Post stroke depression patients will receive Least acupuncture stimulation (LAS). Patients will continue their existing antidepressant and rehabilitation therapy as usual.
Intervention Type
Procedure
Intervention Name(s)
Dense cranial electroacupuncture stimulation
Other Intervention Name(s)
DCEAS
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Body acupuncture
Other Intervention Name(s)
BA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Antidepressant
Intervention Description
Patients will continue their existing antidepressant therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Other Intervention Name(s)
Rehab
Intervention Description
Patients will continue their existing rehabilitation therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.
Intervention Type
Procedure
Intervention Name(s)
Least acupuncture stimulation
Other Intervention Name(s)
LAS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in depression measured by HAMD-17
Description
Depression will be measured using the Hamilton Rating Scale for Depression (HAMD-17). Assessments will be conducted at baseline and once monthly thereafter.
Time Frame
Baseline, 4 week, 8 week
Title
Changes in depression measured by MADRS
Description
Depression will be measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). Assessments will be conducted at baseline and once monthly thereafter.
Time Frame
Baseline, 4 week, 8 week
Title
Changes in depression measured by SDS
Description
Depression will be measured using the Zung Self-Rating Depression Scale (SDS). Assessments will be conducted at baseline and once monthly thereafter.
Time Frame
Baseline, 4 week, 8 week
Title
Changes in locomotor function measured by BI
Description
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.
Time Frame
Baseline, 4 week, 8 week
Title
Changes in cognitive function
Description
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.
Time Frame
Baseline, 4 week, 8 week
Secondary Outcome Measure Information:
Title
Clinical outcome of treatment
Description
It includes clinical response, defined as <50% reduction at endpoint from baseline on HAMD-17, and remission, defined as 7 points or less on HAMD-17 score.
Time Frame
8 week
Title
Emergence of adverse events
Description
Adverse events are assessed using the Treatment Emergent Symptom Scale (TESS).
Time Frame
Baseline, 4 week, 8 week
Title
TCM syndrome diagnosis
Description
To determine Traditional Chinese Medicine (TCM) syndrome correlated of the treatment efficacy, the investigators will conduct TCM syndrome diagnosis. The 5 most common syndromes of PSD are listed below:
Liver Depression with Qi-stagnation;
Liver Depression with Spleen deficiency;
Blood stasis and phlegm obstruction;
Deficiency of Both Heart and Spleen; or
Deficiency of Both Liver and Kidney Yin.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang-Jin ZHANG, MMed, PhD
Organizational Affiliation
School of Chinese Medicine, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Kowloon Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Division of Rehabilitation Medicine, Tung Wah Hospital.
City
Sheung Wan
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Can Acupuncture Treat Post-stroke Depression?
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