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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

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorders Acupuncture Mild Traumatic Brain Injury Other: acupuncture Other: sham acupuncture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in ratings of Rivermead Post-Concussion Symptom Questionnaire [ Time Frame: Baseline, one month ]
  2. Diffusion tensor magnetic metrics changes in patients following acupuncture treatment [ Time Frame: baseline, one month ]
  3. Changes in resting state functional connectivity following acupuncture treatment [ Time Frame: baseline, one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02868671


Contacts
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Contact: Lijun Bai, Ph.D 17818279914 bailj4152615@gmail.com
Contact: Ming Zhang, M.D zmmri@163.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Ming Zhang, M.D       zmmri@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: Ming Zhang, MD First Affiliated Hospital Xi'an Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02868671     History of Changes
Other Study ID Numbers: NSFC81571752
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
mild TBI
Post-traumatic Stress Disorders
Acupuncture
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Wounds and Injuries
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Trauma and Stressor Related Disorders
Mental Disorders
Head Injuries, Closed
Wounds, Nonpenetrating