Integrated Rehabilitation in Treating Post-stroke Depression
IRTPD
1 other identifier
interventional
202
1 country
1
Brief Summary
Post-stroke depression (PSD) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSD exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality and recurrence rates of stroke. Therefore, early clinical treatments for PSD are important to improve the prognosis and restore the social functions of stroke patients. Integrated rehabilitation has significant advantages in the treatment of PSD. First of all, there is a wide range of rehabilitation methods, such as acupuncture, traditional Chinese medicine, and repetitive transcranial magnetic stimulation, which have been proved to be effective for PSD. However, as the application of integrated rehabilitation becomes more and more widespread, its shortcomings are gradually emerging. For example, most of the treatment protocols used in clinical studies are based on personal experience of the investigators, a unified protocol has not yet been formed; treatment methods are still insufficient in standardization and reproducibility. More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy, but ignore the important theoretical basis of the "holistic concept", thus showing the uneven clinical efficacy. For the above existing problems, it is necessary to conduct original and innovative research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedStudy Start
First participant enrolled
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 24, 2022
June 1, 2022
2.9 years
December 3, 2021
June 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in hamilton depression (HAMD) scale
Based on this large study of psychiatric outpatients with major depressive disorder we recommend the following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24). Severity classification on the Hamilton Depression Rating Scale J Affect Disord.
Baseline, at 4-week during treatment, at 8-week follow-up
Change in self-rating depression scale (SDS)
Self-Rating Depression Scale (SDS) Description. This self-report scale was designed to quantify the severity of current major depression in 20 items. The scale was tested for psychometric properties. Various studies showed good to adequate results for validity.
Baseline, at 4-week during treatment, at 8-week follow-up
Change in activity of daily living (ADL) scale
The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are many variations on the definition of the ADLs, but most organizations agree there are 5 basic categories. The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are many variations on the definition of the ADLs, but most organizations agree there are 5 basic categories.
Baseline, at 4-week during treatment, at 8-week follow-up
Secondary Outcomes (3)
Change in montreal cognitive assessment (MoCA) scale
Baseline, at 4-week during treatment, at 8-week follow-up
Change in the simple fugl-meyer assessment of motor function (FMA) scale
Baseline, at 4-week during treatment, at 8-week follow-up
Change in pittsburgh sleep quality index (PSQI)
Baseline, at 4-week during treatment, at 8-week follow-up
Study Arms (2)
Integrated rehabilitation group
EXPERIMENTALThis group will include 101 patients. On the basis of standard care, patients in this group will receive acupuncture, traditional Chinese medicine, repetitive transcranial magnetic stimulation .
Standard care group
ACTIVE COMPARATORThe patients were recommended to take one oral tablet of paroxetine hydrochloride (20 mg) every morning after a meal for 4 weeks. Internal medicine includes lipid regulation, blood sugar control, anti-hypertension, anticoagulation, and other drugs. Moreover, general duty nursing and motor therapy are also needed.
Interventions
Acupuncture: Scalp acupuncture includes middle line of forehead (MS1), a front line by the forehead (MS2), and middle line of vertex (MS5), these acupoints are needled for 1 inch with the direction with scalp tilted 15-30 degrees. Body acupuncture includes Yintang (DU29), Taichong (LR3), Shenmen (HT7), Neiguan (PC6), Danzhong (RN17), Qimen (LR14), Taixi (KI3). Traditional Chinese medicine: Chaihushugan Power: Chaihu 12g, Chenpi 12g, Chuanxiong 9g, vinegar Xiangfu 9g, Zhike 9g, Shaoyao 9g, roasted Gancao 3g. Repetitive transcranial magnetic stimulation: The CCY-I magnetic field stimulator from Wuhan Irid Medical Equipment New Technology Co is used, with a frequency of 10Hz. Standard care: The same as the standard care group.
Eligibility Criteria
You may qualify if:
- Meet the diagnostic criteria of cerebral infarction or cerebral hemorrhage with depression disorder, the type of depression and the clinical syndrome of liver qi stagnation;
- Patients with clear consciousness, stable vital signs, ability to understand and cooperate with instructions, barthel index (BI) \> 20, FMA (0-95), Mini-mental State Examination (MMSE) meet the following criteria: illiterate \> 17, primary school level \> 20, secondary school level (including technical secondary school) \> 22, and college level (including junior college) \> 23 points;
- \<= age \<= 85 years, male or female;
- First episode of stroke, no personal or family history of mental disability before the stroke;
- Depression level as mild or moderate (HAMD scores \>= 7 and \<= 24);
- Depression symptoms occur after the stroke in a clear temporal sequence;
- The course of the PSD is limited to 2 weeks to 36 months after the stroke;
- Participants can understand the study protocol and written informed consent is signed.
You may not qualify if:
- Patients with acute brain trauma, brain infection, effusion, or tumor occupation;
- There are intracranial metals and other foreign bodies (such as orthopedic materials, arterial clips, etc.), cardiac pacemakers, deep brain stimulators, and other electronic devices;
- Previous seizures, including primary and secondary seizures；
- Patients have severe complications in cardiovascular, liver, kidney or psychiatric history ;
- There is a significant cognitive impairment (MMSE: literacy \<= 17, primary school level \<= 20, secondary school level (including technical secondary school) \<= 22, and college level (including junior college) \<= 23 points) or hearing impairment, aphasia;
- Coma, dying or chronic illness;
- Patients have taken psychotropic drugs or been treated for depression for nearly a month;
- People with unstable vital signs or patients with other mental disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000, China
Related Publications (1)
Chen J, Shen K, Fan L, Hu H, Li T, Zhang Y, Gao H. Integrative medicine in treating post-stroke depression: Study protocol for a multicenter, prospective, randomized, controlled trial. Front Psychol. 2022 Aug 29;13:923506. doi: 10.3389/fpsyg.2022.923506. eCollection 2022.
PMID: 36110277DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Gao
Third Affiliated Hospital of Zhejiang Chinese Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy dean
Study Record Dates
First Submitted
December 3, 2021
First Posted
January 12, 2022
Study Start
January 24, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 24, 2022
Record last verified: 2022-06