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NCT Number: NCT05839132

Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients

Traumatic brain injury (TBI) is an altered brain function caused by an external force, which may annually have 69 million incidence cases all over the world. Increasing evidence suggests that TBI may be a major risk of beta amyloid (Aβ)-associated neurodegenerative disorders, such as Alzheimer's disease, frontotemporal dementia, and Parkinson's disease. Investigations from brain imaging studies revealed that Aβ density maps of TBI patients overlapped with those with Alzheimer's disease, and increased Aβ density not only associated with prolonged TBI duration but also associated with decreased white matter integrity. It has been suggested that the axonal injury and cerebrovascular dysfunction due to TBI may associate with the elevated level of Aβ peptides. The increasing accumulation in Aβ due to TBI may contribute to the initiation of the pathological alterations in neurodegeneration diseases. Recent animal studies suggest that acupuncture may promote regeneration of nerves in injured tissues and reduce the concentration of Aβ in brain. Moreover, recent clinical trials also indicate that acupuncture may improve the vascular cognitive impairment due to cerebral small vessel disease. Thus, acupuncture treatment on TBI may not only be of benefit for the TBI recovery but also act to interrupt the pathological changes in these neurodegenerative diseases.

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Key information

Conditions

Neurodegenerative Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 20 years old
  • GCS score > 8
  • loss of consciousness < 24 hr
  • the physical condition is suitable for acupuncture treatment
  • having adequate competency for understanding the study and a willingness to sign the written informed consent forms
  • be able to commence the acupuncture intervention within 2 weeks after TBI diagnosis

Exclusion criteria

  • medical history of neurological, cardiovascular events, e.g., epilepsy, stroke, major depression or anxiety
  • a history of the mental disorder, e.g., major depression or anxiety
  • other major medical conditions, e.g., active cancer, uncontrolled diabetes, amputation
  • receipt of acupuncture within the 6 months prior to study entry
  • patients with pacemaker or metal graf

Treatment and study plan

Acupuncture

Procedure

20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.

Primary outcomes

  1. plasma levels of Aβ peptide

    Time frame: After 2-week acupuncture treatment interva

    Decreased plasma levels of Aβ peptide

  2. plasma levels of tau

    Time frame: After 2-week acupuncture treatment interva

    Decreased plasma levels of tau

  3. plasma levels of glial fibrillary acidic protein (GFAP)

    Time frame: After 2-week acupuncture treatment interva

    Decreased plasma levels of glial fibrillary acidic protein (GFAP)

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Chen Lee, Ph.D

CONTACT

[email protected]

+886-975-682023

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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