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Trial record 49 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

The Effects of Acupuncture on the Risk of AD After TBI

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ClinicalTrials.gov Identifier: NCT03378037
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

December 8, 2017
December 19, 2017
March 8, 2018
December 25, 2017
June 2020   (Final data collection date for primary outcome measure)
  • Decreased plasma levels of Aβ peptide [ Time Frame: After 2-week acupuncture treatment interval ]
  • Decreased plasma levels of tau [ Time Frame: After 2-week acupuncture treatment interval ]
  • Decreased plasma levels of glial fibrillary acidic protein (GFAP) [ Time Frame: After 2-week acupuncture treatment interval ]
Same as current
Complete list of historical versions of study NCT03378037 on ClinicalTrials.gov Archive Site
Increased white matter integrity [ Time Frame: After 2-week acupuncture treatment interval ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Brain Injuries, Traumatic
Procedure: Acupuncture
20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
  • Experimental: Acupuncture group
    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.
    Intervention: Procedure: Acupuncture
  • Sham Comparator: Control 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.
    Intervention: Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
Same as current
June 2020
June 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact: Yu-Chen Lee, Doctor 886-975-682023 d5167@mail.cmuh.org.tw
Taiwan
 
 
NCT03378037
CMUH106-REC2-139
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
China Medical University Hospital
China Medical University Hospital
Not Provided
Not Provided
China Medical University Hospital
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP