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The Effects of Acupuncture on the Risk of AD After TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03378037
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Procedure: Acupuncture

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Acupuncture on the Risk of AD After TBI: A Randomized Controlled Trial
Anticipated Study Start Date : December 25, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Procedure: Acupuncture
20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
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.
Procedure: Acupuncture
20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.

Outcome Measures

Primary Outcome Measures :
  1. Decreased plasma levels of Aβ peptide [ Time Frame: After 2-week acupuncture treatment interval ]
  2. Decreased plasma levels of tau [ Time Frame: After 2-week acupuncture treatment interval ]
  3. Decreased plasma levels of glial fibrillary acidic protein (GFAP) [ Time Frame: After 2-week acupuncture treatment interval ]

Secondary Outcome Measures :
  1. Increased white matter integrity [ Time Frame: After 2-week acupuncture treatment interval ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378037

Contact: Yu-Chen Lee, Doctor 886-975-682023 d5167@mail.cmuh.org.tw

China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Yu-Chen Lee, Doctor    0975-682023    d5167@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
More Information

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03378037     History of Changes
Other Study ID Numbers: CMUH106-REC2-139
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:
Brain Injuries, Traumatic
Alzheimer's disease
Magnetic resonance imaging
white matter integrity

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries