Elsevier

Brain Stimulation

Volume 16, Issue 3, May–June 2023, Pages 819-827
Brain Stimulation

Trigeminal nerve stimulation for prolonged disorders of consciousness: A randomized double-blind sham-controlled study

https://doi.org/10.1016/j.brs.2023.05.002Get rights and content
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open access

Highlights

  • TNS can promote functional recovery (CRS-R and GCS) in patients with prolonged disorders of consciousness.

  • TNS can increase brain metabolism in parahippocampal cortex, precuneus, and middle cingulate cortex according to FDG-PET.

  • TNS is more beneficial for prolonged disorders of consciousness patients caused by brain trauma and stroke.

Abstract

Background

Trigeminal nerve stimulation (TNS) has been proposed as a promising intervention for coma awakening. However, the effect of TNS on patients with prolonged disorders of consciousness (pDoC) is still unclear.

Objective

This study aimed to investigate the therapeutic effects of TNS in pDoC caused by stroke, trauma, and anoxia.

Methods

A total of 60 patients (male =25, female =35) aged over 18 who were in a vegetative state or minimally conscious state were randomly assigned to the TNS (N = 30) or sham TNS (N = 30) groups. 4 weeks of intervention and a followed up for 8 weeks were performed. The Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R) scores as primary outcomes were assessed at baseline and at 2, 4, 8, and 12 weeks.

Results

The score changes in the TNS group over time for CRS-R (2-week: mean difference = 0.9, 95% CI = [0.3, 1.5], P = 0.006; 4-week: 1.6, 95% CI = [0.8, 2.5], P < 0.001; 8-week: mean difference = 2.4, 95% CI = [1.3, 3.5], P < 0.001; 12-week: mean difference = 2.3, 95% CI = [1.1, 3.4], P < 0.001) and GCS (4-week: mean difference = 0.7, 95% CI = [0.3, 1.2], P = 0.002; 8-week: mean difference = 1.1, 95% CI = [0.6, 1.7], P < 0.001; 12-week: 1.1, 95% CI = [0.5, 1.7], P = 0.003) were higher than those in the sham group. 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) revealed that the metabolism of the right parahippocampal cortex, right precuneus, and bilateral middle cingulate cortex was significantly increased in TNS group.

Conclusion

The results of this study indicate that TNS could increase local brain metabolism and may promote functional recovery in patients with prolonged disorders of consciousness.

Registration information

Name of the registry: Chinese Clinical Trial Registry. Registration number: ChiCTR1900025573. The date that the study was submitted to a registry: 2019-09-01. The date when the first patient was enrolled was 2021-01-20.

Keywords

Disorders of consciousness
Trigeminal nerve stimulation
Brain injury
Brain function
Brain metabolism

Abbreviations

CRS-R
Coma Recovery Scale-Revised
DoC
Disorders of Consciousness
FDG-PET
18-Fluorodeoxyglucose Positron Emission Tomography
GCS
Glasgow Coma Scale
LMM
Linear Mixed Model
MNI
Montreal Neurological Institute
MCS
Minimally Consciousness State
pDoC
Prolonged Disorders of Consciousness
SEP
Somatosensory Evoked Potentials
TBI
Traumatic Brain Injury
TNS
Trigeminal Nerve electrical Stimulation
VS
Vegetative State

Cited by (0)

1

These authors are the co-corresponding authors.

2

These authors contributed equally to this work.