The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia

Acupuncture Clinical Trial

Official title:

The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326724
• Other study ID #: CMUH111-REC2-024
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2022
• Source: China Medical University Hospital
• Contact: Ching-Liang Hsieh, Ph.D
• Phone: +886-4-22053366
• Email: clhsieh[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. History of stroke.

2. MMSE score between 16 and 26.

Exclusion Criteria:

1. Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.

2. Intolerance to acupuncture treatment.

3. Allergy to acupuncture needles.

4. Refusal to sign the informed consent form.

Related Conditions & MeSH terms

• Acupuncture
• Dementia
• Post-stroke Dementia
• Stroke

Intervention

Device:
• Acupuncture
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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	North District

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of Exosome		12 weeks
Primary	Alzheimer's Disease Assessment Scale-Cognitive Subscale scale	Higher scores indicate greater cognitive impairment.	12 weeks
Primary	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