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. 2024;54(3):495-504.
doi: 10.3233/NRE-230282.

Combining HD-tDCS with music stimulation for patients with prolonged disorders of consciousness: Study protocol for an RCT trial

Jie Yan  1   2 , Fubing Zha  1 , Juan Zhou  1 , Jing Zhou  1 , Jingpu Zhao  1 , Qingfang Zhang  1   2 , Jianjun Long  1 , Dianrui Hou  3 , Zhenhua Song  4 , Yulong Wang  1
Affiliations

Combining HD-tDCS with music stimulation for patients with prolonged disorders of consciousness: Study protocol for an RCT trial

Jie Yan et al. NeuroRehabilitation. 2024.

Abstract

Background: Patients with prolonged disorders of consciousness (pDOC) pose significant challenges to healthcare workers due to their severe motor impairments and limited interaction with the environment. Non-invasive brain stimulation such as high-definition transcranial direct current stimulation (HD-tDCS) and music stimulation show promise in awakening this population.

Objective: In this study, we present a protocol aiming at investigating the efficacy of combined HD-tDCS and music stimulation in awakening patients with pDOC through a single-blind, randomized controlled trial.

Methods: Ninety patients with pDOC will be randomly divided into three groups: active HD-tDCS with music stimulation, active HD-tDCS, and sham HD-tDCS. All participants will receive 20 treatment sessions over a period of 10 days and the Coma Recovery Scale-Revised, Glasgow Outcome Scale and electroencephalogram will be used as assessment measures to evaluate their level of consciousness throughout the study. Adverse events and complications will be recorded during treatment. Within-group pre-post comparisons and between-group efficacy comparisons will be conducted to identify the most effective intervention approach. Statistical analysis will be performed using SPSS software with a significance level set at P < 0.05.

Conclusion: The pursuit of awakening therapy for patients with pDOC remains a clinical research challenge. This study protocol is designed with the aim of introducing an innovative non-pharmacological approach which combined HD-tDCS and music stimulation to facilitate the reinstatement of consciousness in patients with pDOC.

Keywords: High-definition transcranial direct current stimulation; disorders of consciousness; electroencephalography; music stimulation; neuromodulation; randomized controlled trial.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
HD-tDCS montage. F3 denotes the anodal electrode, while AFz, FCz, F7, and C5 denote cathodal electrodes. The selected montage induces an electric field distribution within the cortical gray matter.
Fig. 2
Fig. 2
Study design. This schematic illustrates the study design, encompassing the chronological sequence of events, participant logistics, and the timing of assessments at various time points including baseline, pre- and post-intervention, post-test, and follow-up. T0: before the first session; T1: after the first session; T2: after ten sessions; T3: after twenty sessions; T4: one week after the end of the twenty sessions; T5: three months after the end of the twenty sessions. Abbreviations: prolonged disorders of consciousness (pDOC); Coma Recovery Scale-Revised (CRS-R); high-definition transcranial direct current stimulation (HD-tDCS); Glasgow Outcome Scale (GOS); Electroencephalogram (EEG).
Fig. 3
Fig. 3
Outline of the experimental design. T0: before the first session; T1: after the first session; T2: after ten sessions; T3: after twenty sessions; T4: one week after the twenty sessions; T5: three months after the end of the twenty sessions.
Fig. 4
Fig. 4
Mesocircuit fronto-parietal model. This mesocircuit model potentially explains the mechanisms of HD-tDCS and music stimulation, which have demonstrated promising results in the recovery of consciousness among patients with prolonged disorders of consciousness (pDOC). The black dotted box shows the neural mechanisms of impaired consciousness. After brain injury, a reduction in central thalamic neurons leads to diminished outputs in the corticothalamic and thalamo-striatal pathways (green lines). Consequently, the inhibitory effect of the striatum on the pallidum interna weakens (dashed red line), allowing the pallidum interna neurons to exhibit tonic firing and exert active inhibition (red line) on their synaptic targets, including the relay neurons in the already significantly impaired central thalamus(Fridman et al., 2014; Fridman and Schiff, 2014). This sequence of events may contribute to the consciousness disorders. Adapted from Giacino and colleagues(Fins and Bernat, 2018).
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