The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
Primary Purpose
Exosome, Post-stroke Dementia, Acupuncture
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Exosome
Eligibility Criteria
Inclusion Criteria:
- History of stroke.
- MMSE score between 16 and 26.
Exclusion Criteria:
- 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.
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture
Arm Description
Outcomes
Primary Outcome Measures
concentration of Exosome
Alzheimer's Disease Assessment Scale-Cognitive Subscale scale
Higher scores indicate greater cognitive impairment.
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 ).
Secondary Outcome Measures
Full Information
NCT ID
NCT05326724
First Posted
March 28, 2022
Last Updated
April 11, 2022
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05326724
Brief Title
The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
Official Title
The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exosome, Post-stroke Dementia, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
concentration of Exosome
Time Frame
12 weeks
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale scale
Description
Higher scores indicate greater cognitive impairment.
Time Frame
12 weeks
Title
Behavioural and Psychological Symptoms of Dementia scale
Description
The greater cognitive impairment or dementia severity is associated with higher rates of some BPSD (Behavioral and psychological symptoms of dementia ).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of stroke.
MMSE score between 16 and 26.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Liang Hsieh, Ph.D
Phone
+886-4-22053366
Ext
3127
Email
clhsieh@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
State/Province
North District
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Liang Hsieh, Ph.D
Phone
+886-4-22053366
Ext
3127
Email
clhsieh@mail.cmuh.org.tw
12. IPD Sharing Statement
Learn more about this trial
The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
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