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

NCT ID: NCT05839132

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Neurodegenerative Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

acupuncture treatment group

Disposable acupuncture needles will be inserted into acupoints for a depth of 20-30 mm in a direction oblique or parallel to the surface. To ensure allocation concealment, all needles will be affixed with plastic O-rings and adhesive tapes.

Acupuncture points: Baihui(DU20), Sishencong(EM1), Hegu(LI4), Taichong(LR3)

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

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

sham acupuncture treatment group

Streitberger's non-invasive placebo acupuncture needles will be used in the control group; blunt-tipped needles will touch the skin quickly without being inserted. To ensure allocation concealment, all needles will be affixed with plastic O-rings and adhesive tapes.

Acupuncture points: Baihui(DU20), Sishencong(EM1), Hegu(LI4), Taichong(LR3)

Group Type: PLACEBO_COMPARATOR

Acupuncture

Intervention Type: PROCEDURE

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

Interventions

Acupuncture

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Chen Lee

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Central Contacts

Yu-Chen Lee, Ph.D

Role: CONTACT

d5167@mail.cmuh.org.tw

+886-975-682023

Facility Contacts

Yu-Chen Lee, Ph.D

Role: primary

d5167@mail.cmuh.org.tw

886-975-682023

Other Identifiers

CMUH111-REC1-239

Identifier Type: -

Identifier Source: org_study_id