Ignite Creation Date:
2024-05-06 @ 8:00 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02644161
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2015-12-18
Brief Title:
Can Acupuncture Treat Post-stroke Depression
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
A Multisite Assessor-blinded Randomized Controlled Trial of Acupuncture for Post-stroke Depression
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSD2
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 2005Paolucci 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 2012Our 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 ie treatment protocol is tailored to meet individuals 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
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 2012Our 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 ie treatment protocol is tailored to meet individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None