StrokePSD2NCT02644161
Can Acupuncture Treat Post-stroke Depression?
A study testing Dense cranial electroacupuncture stimulation, Body acupuncture and Antidepressant in people with Stroke and Depression, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stroke, Depression, Stroke Sequelae
- What is being tested?
- Dense cranial electroacupuncture stimulation, Body acupuncture and Antidepressant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 2 sitesHong Kong
- Study dates
- Oct 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Department of Rehabilitation, Kowloon Hospital
Kowloon
Division of Rehabilitation Medicine, Tung Wah Hospital.
Sheung Wan
About this study
Official title: A Multisite, Assessor-blinded, Randomized Controlled Trial of Acupuncture for Post-stroke Depression
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.
Read the 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.
- Conditions
- Stroke, Depression, Stroke Sequelae
- Being tested
- Dense cranial electroacupuncture stimulation, Body acupuncture, Antidepressant, Rehabilitation, Least acupuncture stimulation
- Keywords
- stroke, depression, stroke sequelae, acupuncture, DCEAS, CAI, LAS
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dense cranial electroacupuncture stimulationProcedure or surgery
Also called DCEAS
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).
Body acupunctureProcedure or surgery
Also called BA
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.
AntidepressantDrug
Patients will continue their existing antidepressant therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.
RehabilitationOther
Also called Rehab
Patients will continue their existing rehabilitation therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.
Least acupuncture stimulationProcedure or surgery
Also called LAS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Antidepressant; Other: Rehabilitation; Procedure: Least acupuncture stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 week, 8 week
Secondary outcomes (3)
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.
Measured: 8 week
Emergence of adverse events
Adverse events are assessed using the Treatment Emergent Symptom Scale (TESS).
Measured: Baseline, 4 week, 8 week
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Hospital, Kowloon Hospital, Hong Kong
- Responsible party
- Principal investigator, Prof. Zhang Zhang-Jin, The University of Hong Kong
- Investigators
- Zhang-Jin ZHANG, MMed, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644161
- Sponsor's protocol ID
- UW 15-421
- Acronym
- PSD2
- Status last verified
- May 2019
- First submitted
- 18 Dec 2015
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bhogal SK, Teasell R, Foley N, Speechley M. Heterocyclics and selective serotonin reuptake inhibitors in the treatment and prevention of poststroke depression. J Am Geriatr Soc. 2005 Jun;53(6):1051-7. doi: 10.1111/j.1532-5415.2005.53310.x.
PubMed 15935033Chung KF, Yeung WF, Yu YM, Yung KP, Zhang SP, Zhang ZJ, Wong MT, Lee WK, Chan LW. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry. 2015 Jun;76(6):e752-60. doi: 10.4088/JCP.14m09124.
PubMed 26132682Chung KF, Yeung WF, Zhang ZJ, Yung KP, Man SC, Lee CP, Lam SK, Leung TW, Leung KY, Ziea ET, Taam Wong V. Randomized non-invasive sham-controlled pilot trial of electroacupuncture for postpartum depression. J Affect Disord. 2012 Dec 15;142(1-3):115-21. doi: 10.1016/j.jad.2012.04.008. Epub 2012 Jul 26.
PubMed 22840621Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Gustafson Y, Nilsson I, Mattsson M, Astrom M, Bucht G. Epidemiology and treatment of post-stroke depression. Drugs Aging. 1995 Oct;7(4):298-309. doi: 10.2165/00002512-199507040-00005.
PubMed 8535057Hammerschlag R. Methodological and ethical issues in clinical trials of acupuncture. J Altern Complement Med. 1998 Summer;4(2):159-71. doi: 10.1089/acm.1998.4.159.
PubMed 9628206Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci. 2003 Jan;26(1):17-22. doi: 10.1016/s0166-2236(02)00006-1. No abstract available.
PubMed 12495858Hemeryck A, Belpaire FM. Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: an update. Curr Drug Metab. 2002 Feb;3(1):13-37. doi: 10.2174/1389200023338017.
PubMed 11876575Huang Y, Chen J, Zou J. effects of scalp electroacupuncture on post-stroke depression. Zhong Guo Kang Fu 2005,9:172-173.
Huang Y, Xia DB. [Clinical observation on treatment of depression with scalp electro-acupuncture: a report of 30 cases]. Zhong Xi Yi Jie He Xue Bao. 2004 Mar;2(2):151. doi: 10.3736/jcim20040225. No abstract available. Chinese.
PubMed 15339485Lee AC, Tang SW, Leung SS, Yu GK, Cheung RT. Depression literacy among Chinese stroke survivors. Aging Ment Health. 2009 May;13(3):349-56. doi: 10.1080/13607860802636230.
PubMed 19484598MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255.
PubMed 25038733Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
PubMed 444788Manheimer E, Linde K, Lao L, Bouter LM, Berman BM. Meta-analysis: acupuncture for osteoarthritis of the knee. Ann Intern Med. 2007 Jun 19;146(12):868-77. doi: 10.7326/0003-4819-146-12-200706190-00008.
PubMed 17577006
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisite, Assessor-blinded, Randomized Controlled Trial of Acupuncture for Post-stroke Depression
- ClinicalTrials.gov ID
- NCT02644161
- Acronym / sponsor ID
- PSD2 / UW 15-421
- Conditions
- Stroke, Depression, Stroke Sequelae
- Keywords
- stroke, depression, stroke sequelae, acupuncture, DCEAS, CAI, LAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Tung Wah Hospital, Kowloon Hospital, Hong Kong
- Study start
- Oct 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination acupuncture treatment (CAI) | Active comparator | Procedure: Dense cranial electroacupuncture stimulation, Procedure: Body acupuncture, Drug: Antidepressant, Other: RehabilitationPost stroke depression patients will receive Dense Cranial Electroacupuncture Stimulation (DCEAS) and body acupuncture. Patients will continue their existing antidepressant and rehabilitation therapy as usual. |
| Least acupuncture stimulation (LAS) | Sham comparator | Drug: Antidepressant, Other: Rehabilitation, Procedure: Least acupuncture stimulationPost stroke depression patients will receive Least acupuncture stimulation (LAS). Patients will continue their existing antidepressant and rehabilitation therapy as usual. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dense cranial electroacupuncture stimulationAlso: DCEASDCEAS 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 or surgery | Combination acupuncture treatment (CAI) |
| Body acupunctureAlso: BAFollowing 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. | Procedure or surgery | Combination acupuncture treatment (CAI) |
| AntidepressantPatients will continue their existing antidepressant therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion. | Drug | Combination acupuncture treatment (CAI), Least acupuncture stimulation (LAS) |
| RehabilitationAlso: RehabPatients will continue their existing rehabilitation therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion. | Other | Combination acupuncture treatment (CAI), Least acupuncture stimulation (LAS) |
| Least acupuncture stimulationAlso: LASThe 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. | Procedure or surgery | Least acupuncture stimulation (LAS) |
Primary outcome
Changes in depression measured by HAMD-17
Time frame: Baseline, 4 week, 8 week
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
Time frame: Baseline, 4 week, 8 week
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
Time frame: Baseline, 4 week, 8 week
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
Time frame: Baseline, 4 week, 8 week
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
Time frame: Baseline, 4 week, 8 week
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.
3 secondary outcomes
Clinical outcome of treatment
Time frame: 8 week
Emergence of adverse events
Time frame: Baseline, 4 week, 8 week
TCM syndrome diagnosis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Background: PubMed 15935033Bhogal SK, Teasell R, Foley N, Speechley M. Heterocyclics and selective serotonin reuptake inhibitors in the treatment and prevention of poststroke depression. J Am Geriatr Soc. 2005 Jun;53(6):1051-7. doi: 10.1111/j.1532-5415.2005.53310.x.
- Background: PubMed 26132682Chung KF, Yeung WF, Yu YM, Yung KP, Zhang SP, Zhang ZJ, Wong MT, Lee WK, Chan LW. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry. 2015 Jun;76(6):e752-60. doi: 10.4088/JCP.14m09124.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang-Jin ZHANG, MMed, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dense cranial electroacupuncture stimulation, Body acupuncture and Antidepressant in people with Stroke and Depression, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depression measured by HAMD-17 (time frame: Baseline, 4 week, 8 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02644161, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019; AzTrials last refreshed its copy on 30 Oct 2026.