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

Sponsor
China Medical University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05326724
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Acupuncture
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acupuncture

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.

Outcome Measures

Primary Outcome Measures

  1. concentration of Exosome [12 weeks]

  2. Alzheimer's Disease Assessment Scale-Cognitive Subscale scale [12 weeks]

    Higher scores indicate greater cognitive impairment.

  3. Behavioural and Psychological Symptoms of Dementia scale [12 weeks]

    The greater cognitive impairment or dementia severity is associated with higher rates of some BPSD (Behavioral and psychological symptoms of dementia ).

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Hospital Taichung North District Taiwan 40447

Sponsors and Collaborators

  • China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT05326724
Other Study ID Numbers:
  • CMUH111-REC2-024
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke
Dementia

Study Results

No Results Posted as of Apr 13, 2022