The Effects of Acupuncture on the Risk of AD After TBI

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03378037
• Other study ID #: CMUH106-REC2-139
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2017
• Last updated: March 6, 2018
• Start date: December 25, 2017
• Est. completion date: June 2020

Study information

• Verified date: March 2018
• Source: China Medical University Hospital
• Contact: Yu-Chen Lee, Doctor
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

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	Decreased plasma levels of Aß peptide		After 2-week acupuncture treatment interval
Primary	Decreased plasma levels of tau		After 2-week acupuncture treatment interval
Primary	Decreased plasma levels of glial fibrillary acidic protein (GFAP)		After 2-week acupuncture treatment interval
Secondary	Increased white matter integrity		After 2-week acupuncture treatment interval