Acupuncture for Mild Traumatic Brain Injury With Post-traumatic Stress Disorder : A Functional Magnetic Resonance Imaging Study

Overview

The overall goal of this study is to examine if acupuncture intervention can reduce the onset of post-traumatic stress disorder (PTSD), and affective and cognitive complaints among mild traumatic brain injury (TBI). This study also hypothesized that compared to those in the sham acupuncture and waiting list control groups, patients in the real acupuncture group will have fewer symptoms of depressive symptoms, sleep problems and post-concussion symptoms.

Full Title of Study: “Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2020

Detailed Description

Project Background: Acupuncture has been shown in other settings to alleviate symptoms of TBI that are reported to be precursors of post-traumatic stress disorder (PTSD), including affective (depression, anxiety) and somatic (headache, sleep difficulties) complaints. Evidence suggests that the increased intensity of these symptoms, particularly greater affective distress and injury-associated pain, increases vulnerability to PTSD. By treating post-TBI symptoms with acupuncture, these predisposing conditions will improve, and, as a result, the incidence of PTSD in this patient population will be reduced.

Research plan: The overarching focus of this study is the use of acupuncture treatment, targeted to symptoms of mild TBI, to reduce the onset of PTSD. The investigators propose a randomized, sham procedure and usual care-controlled clinical trial of acupuncture beginning at acute phase following mild traumatic brain injury (TBI). Participants meeting eligibility requirements will be randomized to 1 of 3 groups: true acupuncture, sham acupuncture or usual care. Acupuncture treatments will continue for one month, at which point all participants will be assessed for presence of mild TBI symptoms, PTSD symptoms, and PTSD diagnosis. Participants will be evaluated again after one-month acupuncture treatment and follow-up post-hospital discharge. The investigators hypothesize that true acupuncture will be more effective than sham acupuncture and usual care in reducing these outcomes at after treatment and follow-up stage. A subgroup of patients were also randomized selected in each group and scanned by 3T MRI scanner at baseline, one-month (after acupuncture treatment) and follow-up.

Interventions

  • Other: acupuncture
  • Other: sham acupuncture

Arms, Groups and Cohorts

  • Experimental: real acupuncture
    • Participants will receive treatment four times a week for two weeks and three times a week for two weeks. Participants will be treated with major points: Yintang, Du20 (Bai Hui), LI4 (He Gu), LR3 (Tai Chong), RN4 (Guan Yuan), ST36 (Zusanli) (front treatment) or Du20, GB20 (Feng Chi), SP6 (Sanyinjiao), BL15 (Xin Shu), BL18 (Gan Shu), BL23 (Shen Shu) (back treatment). The position of the treatment will alternate between sessions such that the first session will be on the back, with the next session on the front. In addition to the 6 required points, acupuncturist will be allowed to choose 4 more points. The 4 supplemental points may be chosen from the following: LR2 (Xin Jian), HT7 (Shenmen), PC6 (Neiguan), GB34 (Yang Ling Quan), GB39 (Xuan Zhong), SI3 (Hou Xi), RN6 (Qi Hai), RN24 (Cheng Jiang),KI 3 (Taixi), KI 6 (Zhao Hai), ST40 (Feng Long), SP10 (Xue Hai), BL14 (Jue Yin Shu), BL17 (Ge Shu), BL19 (Dan Shu), BL20 (Pi Shu), BL60 (Kun Lun). Auricular acupuncture will be employed.
  • Sham Comparator: sham acupuncture
    • Participants randomized to sham acupuncture will receive a ‘placebo’ acupuncture session. In the sham procedure, a needle guiding tube will be tapped on the surface of the skin near, but not on, each of the 10 acupuncture points that would have been selected for true acupuncture. The needle guiding tube will be used to create sensations that mimic needle manipulation.
  • No Intervention: No Intervention
    • All participants in this study will receive usual care. For those assigned to true acupuncture and sham acupuncture, the usual care will be in addition to their acupuncture.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in responses to the Clinician-Administered post-traumatic stress disorder (PTSD) Scale in patients following acupuncture treatments between baseline and one month
    • Time Frame: Baseline, one month

Secondary Measures

  • Changes in ratings of Rivermead Post-Concussion Symptom Questionnaire
    • Time Frame: Baseline, one month
  • Diffusion tensor magnetic metrics changes in patients following acupuncture treatment
    • Time Frame: baseline, one month
  • Changes in resting state functional connectivity following acupuncture treatment
    • Time Frame: baseline, one month

Participating in This Clinical Trial

Inclusion Criteria

  • subjects presenting to the study hospital emergency department (ED) after sustaining a acute head injury will be eligible if they:
  • are aged 18-75 years;
  • have a mild TBI, defined by the World Health Organization's Collaborating Centre for Neurotrauma Task Force (2005)
  • no contraindications to MR
  • injury within 7 days

Exclusion Criteria

  • experience with acupuncture treatment
  • history of neurological disease, long-standing psychiatric condition, spinal cord injury, head injury, or a history of substance or alcohol abuse
  • intubation and/or presence of a skull fracture
  • administration of sedatives on arrival in the emergency department,
  • the manifestation of mild traumatic brain injury (TBI) due to medications by other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital Xi’an Jiaotong University
  • Collaborator
    • Second Affiliated Hospital of Wenzhou Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ming Zhang, MD, Principal Investigator, First Affiliated Hospital Xi’an Jiaotong University
  • Overall Contact(s)
    • Lijun Bai, Ph.D, 17818279914, bailj4152615@gmail.com

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