NCT03378037

The Effects of Acupuncture on the Risk of AD After TBI

The Effects of Acupuncture on the Risk of AD After TBI: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Traumatic brain injury (TBI) is a severely disabling injury which affects 150-200 people per million annually. Increasing evidence suggests that TBI may be a major risk of dementia, Alzheimer's disease (AD) in particular. Postmortem evidence has shown that beta-amyloid (Aβ) deposits, one of the most validated pathological biomarkers of AD, are present in the brains of severe TBI patients. Although the underlying mechanisms remain unclear, the axonal injury may play a role. Imaging investigations have revealed Aβ density maps of TBI patients overlapped with those of AD patients, and increased Aβdensity not only associated with prolonged TBI duration but also associated with decreased white matter integrity. Hence, the increasing accumulation in Aβ due to TBI may contribute to the initiation of the pathological alterations seen in AD. Treatment of TBI may not only be of benefit for the injury itself but also act to block the pathological changes in AD. As a part of the clinical arm of the project, in this subproject investigators will conduct a single-blind, block-randomized clinical trial to investigate the efficacy of acupuncture in TBI. More specifically, investigators hypothesize that acupuncture intervention will elicit neuroprotective processes and thereby reduce axonal damage in TBI, manifested as (1) decreased plasma levels of Aβ peptide, tau, and glial fibrillary acidic protein (GFAP) and (2) increased white matter integrity after acupuncture. Ninety-six participants will be randomly allocated to the acupuncture intervention (verum acupuncture) or control group (sham acupuncture) in a 1:1 ratio. All participants will receive 20 minutes of acupuncture treatment twice a week for 2 weeks. A set of commonly used acupoints for TBI treatment will be manually stimulated every 10 minutes. The multi-modality magnetic resonance imaging (T1, T2, and diffusion tensor imaging) and blood sample will be taken before and after the acupuncture session to measure the white matter integrity in brain and plasma levels of Aβ peptide, tau, and GFAP, respectively. After integrate these data with other subprojects, we can provide synergic and integrative mechanisms of the effects of acupuncture on the risk of AD after TBI.

Conditions

• Brain Injuries, Traumatic

Interventions

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

Timeline

• Start date: 2017-12-25
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-12-19
• Last updated: 2018-03-08

Locations

1 site across 1 country: Taiwan