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

China Medical University

Status: Not yet enrolling

Conditions: Neurodegenerative Diseases

Treatments: Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05839132

CMUH111-REC1-239

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

76 participants in 2 patient groups, including a placebo group

acupuncture treatment group

Experimental group

Description:

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)

Treatment:

Procedure: Acupuncture

sham acupuncture treatment group

Placebo Comparator group

Description:

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)

Treatment:

Procedure: Acupuncture