The Effects of Acupuncture on the Risk of AD After TBI

Not Applicable

• Conditions: Brain Injuries, Traumatic
• Interventions: Procedure: Acupuncture

• Registration Number: NCT03378037
• Lead Sponsor: China Medical University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-17
• Study First Posted: 2017-12-19
• Study Start: 2017-12-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. age ≥ 20 years old
2. GCS score > 13
3. LOC < 30 minutes
4. hospital admission < 7 days
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, or mental disorder, e.g., epilepsy, stroke, major depression or anxiety
2. other major medical conditions, e.g., active cancer, uncontrolled diabetes, pregnancy
3. surgery for TBI
4. receipt of acupuncture within the 6 months prior to study entry
5. patients with pacemaker, metal graft, or claustrophobia
6. preparing for pregnancy during the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Acupuncture	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 group	Acupuncture	Disposable acupuncture needles will be inserted into acupoints for a depth of 10-30 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.

Primary Outcome Measures

Name	Time	Method
Decreased plasma levels of Aβ peptide	After 2-week acupuncture treatment interval
Decreased plasma levels of tau	After 2-week acupuncture treatment interval
Decreased plasma levels of glial fibrillary acidic protein (GFAP)	After 2-week acupuncture treatment interval

Secondary Outcome Measures

Name	Time	Method
Increased white matter integrity	After 2-week acupuncture treatment interval

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan