Acupuncture for Mild Traumatic Brain Injury：A Functional Magnetic Resonance Imaging Study

Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial

The overall goal of this study is to examine if acupuncture intervention can reduce the post-concussion symptom (PCS), 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 depression, sleep problems and post-concussion symptoms.

Study Overview

• Status: Completed
• Conditions: MRI; Mild Traumatic Brain Injury; Acupuncture
• Intervention / Treatment: Other: acupuncture; Other: sham acupuncture

Detailed Description

Project Background: Acupuncture has been shown in other settings to alleviate symptoms of TBI that are reported to be precursors of post-concussion symptom, 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 neurodegenerative disease and PTSD. By treating post-TBI symptoms with acupuncture, these predisposing conditions will improve, and, as a result, the incidence of PCS 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. 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: verum acupuncture, sham acupuncture or waiting-list control. Acupuncture treatments will continue for one month, at which point all participants will be assessed for presence of mild TBI symptoms. 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 in reducing these outcomes at after treatment and follow-up stage. Patients were also scanned by 3T MRI scanner at baseline, one-month (after acupuncture treatment).

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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), ST36 (Zusanli) (front treatment) or 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 5 required points, acupuncturist will be allowed to choose 1-3 more points. The supplemental points may be chosen from the following: HT7 (Shenmen), PC6 (Neiguan), SI3 (Hou Xi), RN6 (Qi Hai), KI 3 (Taixi), KI 6 (Zhao Hai), SP10 (Xue Hai), BL14 (Jue Yin Shu), BL17 (Ge Shu), BL20 (Pi Shu).	Other: acupuncture
Sham Comparator: sham acupuncture; Participants randomized to sham acupuncture will receive a 'placebo' acupuncture session. For sham acupuncture, Streitberger needles, which acted like stage dagger with the shaft of the needle retracting into the handle, were placed at non-acupuncture points with the same number of acupuncture points in the VA group. 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 not receive interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in PCS in patients following acupuncture treatments between baseline and after therapy	Baseline, after one-month therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Diffusion tensor magnetic metrics changes in patients following acupuncture treatment	baseline, one month
Changes in PCS in patients following acupuncture treatments between baseline and 6-12 months follow-up	Baseline, 6-12 months follow-up

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Ming Zhang, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: August 14, 2016
• First Posted (Estimated): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; mild TBI; post-concussion sydrome
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: NSFC81571752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No