The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
1 other identifier
interventional
30
1 country
1
Brief Summary
Stroke is the main cause of disability and the second main cause of dementia. Approximately 21.5% of patients develop dementia within 4 years after stroke. The main clinical manifestation of dementia is memory and cognitive impairment. At present, acetylcholinesterase inhibitors and NMDA glutamate receptor antagonists, were used for dementia treatment, but those drugs have limited efficacy. Exosome is an extracellular vesicle from the endosomal, size range from \~40 to 160 nm (average \~100 nm). It contains many cells including DNA, RNA, fat, and metabolites, as well as cytoplasm and cell surface proteins that play a role in regulating intercellular communication. Some studies believe that exosomes in the circulation are an ideal marker to reflect the pathological progress and recovery of stroke, and play a key role in the reorganization of tissues and the progress of neurodegeneration after stroke. Our previous studies have known that acupuncture can increase the long-term potentiation of hippocampal CA1 in rats with ischemic stroke, and improve learning-memory and neurological function. Therefore, the purpose of this study is to explore the role of acupuncture-induced exosome in the treatment of post-stroke dementia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 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
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedApril 13, 2022
April 1, 2022
3 years
March 28, 2022
April 11, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
concentration of Exosome
12 weeks
Alzheimer's Disease Assessment Scale-Cognitive Subscale scale
Higher scores indicate greater cognitive impairment.
12 weeks
Behavioural and Psychological Symptoms of Dementia scale
The greater cognitive impairment or dementia severity is associated with higher rates of some BPSD (Behavioral and psychological symptoms of dementia ).
12 weeks
Study Arms (1)
Acupuncture
EXPERIMENTALInterventions
The stainless steel needles are used to insert into the three points of Sishencong and the Baihui, and the Dazhui, once a week, once for 20 minutes, for 12 consecutive weeks.
Eligibility Criteria
You may qualify if:
- History of stroke.
- MMSE score between 16 and 26.
You may not qualify if:
- Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.
- Intolerance to acupuncture treatment.
- Allergy to acupuncture needles.
- Refusal to sign the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, North District, 40447, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2022
First Posted
April 13, 2022
Study Start
August 1, 2022
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
April 13, 2022
Record last verified: 2022-04