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

NCT ID: NCT05326724

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Exosome Post-stroke Dementia Acupuncture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Medical University Hospital

Taichung, North District, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ching-Liang Hsieh, Ph.D

Role: CONTACT

+886-4-22053366 ext. 3127

Facility Contacts

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Ching-Liang Hsieh, Ph.D

Role: primary

+886-4-22053366 ext. 3127

Other Identifiers

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CMUH111-REC2-024

Identifier Type: -

Identifier Source: org_study_id

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