Status:
UNKNOWN
Integrated Rehabilitation in Treating Post-stroke Depression
Lead Sponsor:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborating Sponsors:
Zhejiang General Hospital of Armed Police
Hangzhou Hospital of Traditional Chinese Medicine
Conditions:
Post-stroke Depression
Eligibility:
All Genders
25-85 years
Phase:
NA
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 incre...
Detailed Description
This randomized controlled trial will enroll 202 PSD patients from the Third Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang General Hospital of Armed Police, Hangzhou TCM Hospita...
Eligibility Criteria
Inclusion
- 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;
- 25 \<= 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT05187975
Start Date
January 24 2022
End Date
December 31 2024
Last Update
June 24 2022
Active Locations (1)
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1
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310000