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

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ClinicalTrials.gov Identifier: NCT02868671
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Second Affiliated Hospital of Wenzhou Medical University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Tracking Information
First Submitted Date  ICMJE July 21, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date May 7, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02868671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Mild Traumatic Brain Injury With Post-traumatic Stress Disorder : A Functional Magnetic Resonance Imaging Study
Official Title  ICMJE Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-traumatic Stress Disorders
  • Acupuncture
  • Mild Traumatic Brain Injury
Intervention  ICMJE
  • Other: acupuncture
  • Other: sham acupuncture
Study Arms  ICMJE
  • 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.
    Intervention: Other: acupuncture
  • 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.
    Intervention: Other: sham acupuncture
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lijun Bai, Ph.D 17818279914 bailj4152615@gmail.com
Contact: Ming Zhang, M.D zmmri@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02868671
Other Study ID Numbers  ICMJE NSFC81571752
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor  ICMJE First Affiliated Hospital Xi'an Jiaotong University
Collaborators  ICMJE Second Affiliated Hospital of Wenzhou Medical University
Investigators  ICMJE
Principal Investigator: Ming Zhang, MD First Affiliated Hospital Xi'an Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date April 2019

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