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

Neurodegenerative Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05839132
• Other study ID #: CMUH111-REC1-239
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2023
• Source: China Medical University Hospital
• Contact: Yu-Chen Lee, Ph.D
• Phone: +886-975-682023
• Email: d5167[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. age = 20 years old

2. GCS score > 8

3. loss of consciousness < 24 hr

4. the physical condition is suitable for acupuncture treatment

5. having adequate competency for understanding the study and a willingness to sign the written informed consent forms

6. be able to commence the acupuncture intervention within 2 weeks after TBI diagnosis

Exclusion Criteria:

1. medical history of neurological, cardiovascular events, e.g., epilepsy, stroke, major depression or anxiety

2. a history of the mental disorder, e.g., major depression or anxiety

3. other major medical conditions, e.g., active cancer, uncontrolled diabetes, amputation

4. receipt of acupuncture within the 6 months prior to study entry

5. patients with pacemaker or metal graf

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Neurodegenerative Diseases

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

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	plasma levels of Aß peptide	Decreased plasma levels of Aß peptide	After 2-week acupuncture treatment interva
Primary	plasma levels of tau	Decreased plasma levels of tau	After 2-week acupuncture treatment interva
Primary	plasma levels of glial fibrillary acidic protein (GFAP)	Decreased plasma levels of glial fibrillary acidic protein (GFAP)	After 2-week acupuncture treatment interva