Dataset Information

Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Traumatic brain injury (TBI) has become a leading cause of death among young people worldwide. Survivors may live with a long-term TBI-related disability or even develop a disorder of consciousness resulting in poor life quality and shortened life expectancy. Thus far, very few approaches have been found to be effective in the consciousness recovery of these patients. Acupuncture has long been used in the treatment of neurological disorders in China. However, its efficacy and safety in consciousness recovery remain to be proved.

Methods

Here, we present a study design and protocol of a randomized, blinded, controlled study to evaluate the efficacy and safety of electro-acupuncture in the consciousness recovery of patients with TBI. A total of 150 patients with initial Glasgow coma scale score of less than 8 points will be recruited in the trial and randomized into acupuncture or control groups. Patients in the control group will receive routine pharmacological treatment alone while patients in the acupuncture group will receive electro-acupuncture treatment for 10 days in addition to routine treatment. The efficacy will be assessed with the changes in Glasgow coma scale score and mismatch negativity of event-related brain potentials before and after treatment. Moreover, Glasgow outcome scale and Barthel index of activities of daily living will be compared between the two groups at 3 months after treatment. The secondary outcome measures are the length of stay in ICU and hospital, expenses in ICU and hospital, as well as the incidence of coma-related complications. The safety of electro-acupuncture will be assessed by monitoring the incidence of adverse events and changes in vital signs during the study.

Discussion

Results from this trial will significantly add to the current body of evidence on the role of electro-acupuncture in the consciousness recovery of patients with severe TBI. In addition, a more convenient and consistent electro-acupuncture method can be set up for clinical practice. If found to be effective and safe, electro-acupuncture will be a valuable complementary option for comatose patients with TBI.

Trial registration

Chinese Clinical Trial Registry: ChiCTR-INR-17011674 . Registered on 16 June 2016.

SUBMITTER: Liu J

PROVIDER: S-EPMC5975471 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial.

Liu Jie J Xue Xinsheng X Wu Ying Y Yang Chaohua C Li Ning N Li Huiping H

Trials 20180529 1

<h4>Background</h4>Traumatic brain injury (TBI) has become a leading cause of death among young people worldwide. Survivors may live with a long-term TBI-related disability or even develop a disorder of consciousness resulting in poor life quality and shortened life expectancy. Thus far, very few approaches have been found to be effective in the consciousness recovery of these patients. Acupuncture has long been used in the treatment of neurological disorders in China. However, its efficacy and ...[more]

PMID: 29843761

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Project description:Background Acupuncture is one of the most popular complementary and alternative treatments for knee osteoarthritis (KOA). There are many methods of acupuncture in the treatment of KOA, and the effects are different. According to our clinical observations and researches, it is found that manual acupuncture (MA), electro-acupuncture (EA), and warm acupuncture (WA) are used more frequently in the treatment of KOA, and the curative effects are satisfactory. However, there is currently a lack of efficacy comparison of efficacy between different acupuncture treatments, as well as a lack of standardized clinical research on the acupuncture treatment of KOA. Therefore, we will carry out a high-quality clinical randomized controlled trial to research the effect laws of MA, EA, and WA on KOA. Methods/design A total of 200 eligible participants with KOA will be randomly assigned to group A, B, C, or D in a ratio of 1:1:1:1. Patients in group A will receive MA, while those in group B, group C, and group D will be treated with EA, WA, and sham acupuncture (SA), respectively. Patients will be treated with acupuncture once a day, 30 min per session, 5 sessions per week for 4 weeks. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 4. The secondary outcomes include WOMAC, visual analog scale (VAS), Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Credibility/Expectancy Questionnaire. The evaluation will be performed at baseline and weeks 4, 8, and 12 respectively after randomization. Discussion This is a randomized controlled trial. We will observe the clinical effect of MA, EA, and WA on KOA to research the effect laws of these three acupuncture treatments on KOA and set up standardized treatment programs for acupuncture for KOA. Trial registration China Clinical Trials Registry ChiCTR2100049526. Registered on August 2, 2021 Supplementary Information The online version contains supplementary material available at 10.1186/s13063-022-06653-7.

Project description:See Schiff (doi:10.1093/awx209) for a scientific commentary on this article. Patients with acute severe traumatic brain injury may recover consciousness before self-expression. Without behavioural evidence of consciousness at the bedside, clinicians may render an inaccurate prognosis, increasing the likelihood of withholding life-sustaining therapies or denying rehabilitative services. Task-based functional magnetic resonance imaging and electroencephalography techniques have revealed covert consciousness in the chronic setting, but these techniques have not been tested in the intensive care unit. We prospectively enrolled 16 patients admitted to the intensive care unit for acute severe traumatic brain injury to test two hypotheses: (i) in patients who lack behavioural evidence of language expression and comprehension, functional magnetic resonance imaging and electroencephalography detect command-following during a motor imagery task (i.e. cognitive motor dissociation) and association cortex responses during language and music stimuli (i.e. higher-order cortex motor dissociation); and (ii) early responses to these paradigms are associated with better 6-month outcomes on the Glasgow Outcome Scale-Extended. Patients underwent functional magnetic resonance imaging on post-injury Day 9.2 ± 5.0 and electroencephalography on Day 9.8 ± 4.6. At the time of imaging, behavioural evaluation with the Coma Recovery Scale-Revised indicated coma (n = 2), vegetative state (n = 3), minimally conscious state without language (n = 3), minimally conscious state with language (n = 4) or post-traumatic confusional state (n = 4). Cognitive motor dissociation was identified in four patients, including three whose behavioural diagnosis suggested a vegetative state. Higher-order cortex motor dissociation was identified in two additional patients. Complete absence of responses to language, music and motor imagery was only observed in coma patients. In patients with behavioural evidence of language function, responses to language and music were more frequently observed than responses to motor imagery (62.5-80% versus 33.3-42.9%). Similarly, in 16 matched healthy subjects, responses to language and music were more frequently observed than responses to motor imagery (87.5-100% versus 68.8-75.0%). Except for one patient who died in the intensive care unit, all patients with cognitive motor dissociation and higher-order cortex motor dissociation recovered beyond a confusional state by 6 months. However, 6-month outcomes were not associated with early functional magnetic resonance imaging and electroencephalography responses for the entire cohort. These observations suggest that functional magnetic resonance imaging and electroencephalography can detect command-following and higher-order cortical function in patients with acute severe traumatic brain injury. Early detection of covert consciousness and cortical responses in the intensive care unit could alter time-sensitive decisions about withholding life-sustaining therapies.

Dataset Information

Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial.

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