Clinical trial NCT02868671: Acupuncture for Mild Traumatic Brain Injury：A Functional Magnetic Resonance Imaging Study
Official title: Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Mild Traumatic Brain Injury
MRI
Keywords: mild TBI
post-concussion sydrome
Acupuncture
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Wenzhou Medical University
First posted: 2016-08-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility 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

Primary outcomes:
measure: Changes in PCS in patients following acupuncture treatments between baseline and after therapy
timeFrame: Baseline, after one-month therapy
Secondary outcomes:
measure: Changes in PCS in patients following acupuncture treatments between baseline and 6-12 months follow-up
timeFrame: Baseline, 6-12 months follow-up
measure: Diffusion tensor magnetic metrics changes in patients following acupuncture treatment
timeFrame: baseline, one month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Ming Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: