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

NCT02868671 | Completed DMC

• 1 other identifier: NSFC81571752
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Mild Traumatic Brain Injury; MRI

Keywords

mild TBI; post-concussion sydrome; Acupuncture

Outcome Measures

Primary Outcomes (1)

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

  Baseline, after one-month therapy

Secondary Outcomes (2)

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

  Baseline, 6-12 months follow-up

• Diffusion tensor magnetic metrics changes in patients following acupuncture treatment

  baseline, one month

Study Arms (3)

real acupuncture

EXPERIMENTAL

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 acupuncture

SHAM COMPARATOR

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.

Interventions

acupuncture OTHER

real acupuncture

sham acupuncture OTHER

sham acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Second Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ming Zhang, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 16, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 25, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)