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Completed

NCT Number: NCT02868671

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

Sham Acupuncture

Other

Primary outcomes

  1. Changes in PCS in patients following acupuncture treatments between baseline and after therapy

    Time frame: Baseline, after one-month therapy

Secondary outcomes

  1. Changes in PCS in patients following acupuncture treatments between baseline and 6-12 months follow-up

    Time frame: Baseline, 6-12 months follow-up

  2. Diffusion tensor magnetic metrics changes in patients following acupuncture treatment

    Time frame: baseline, one month

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2016
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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