Combining transcranial direct current stimulation with music therapy improves cognitive function in schizophrenia: study protocol for a randomized, double-blind, sham-controlled clinical trial

Abstract

Background: Despite numerous pharmacological treatments, individuals with schizophrenia continue to exhibit significant residual cognitive impairments, adversely affecting the progression of the illness and their overall quality of life. Preliminary evidence indicates that transcranial direct current stimulation (tDCS) and music therapy (MT) may offer potential benefits for enhancing cognitive function in schizophrenia. This study aims to examine the synergistic efficacy of tDCS and MT on cognitive impairments in individuals with schizophrenia and to elucidate the potential mechanisms involved in this process.

Methods: The study is designed as a randomized, double-blind, sham-controlled trial. All patients with schizophrenia will be randomly assigned to one of five groups: active tDCS combined with MT group, sham tDCS combined with MT group, active tDCS group, MT group, and a control group. The anodal electrode of tDCS will be positioned over the medial prefrontal cortex (mPFC), while the cathodal electrode will be placed over the visual cortex. MT will incorporate both Western Mozart and traditional Chinese classical music. The protocol involves 30-minute sessions conducted once daily, 5 days per week, for 4 consecutive weeks. The primary outcome measure is change in cognitive function, secondary outcomes include changes in psychotic symptoms, social function, and quality of life. Assessments will be evaluated at baseline (T0), after 2 weeks (T1), and after 4 weeks (T2). Furthermore, we will employ functional near-infrared spectroscopy (fNIRS) to examine hemodynamic changes on the cerebral cortex, and explore the neural effects of this combined treatment approach.

Discussion: This study proposes an innovative non-pharmacological treatment protocol that combines tDCS targeting the mPFC with MT to improve cognitive impairments in schizophrenia. As a proof-of-concept study, it aims to provide empirical evidence for the effectiveness of this combined intervention. Moreover, this study seeks to elucidate the underlying neural mechanisms and offer a rigorous framework for future clinical trials, ultimately providing a novel therapeutic strategy for enhancing cognitive functions in patients with schizophrenia.

Clinical trial registration: https://www.chictr.org.cn/, identifier, ChiCTR2400093161.

Trial registration details: The study is registered with https://www.chictr.org.cn/ under protocol registration number ChiCTR2400093161 (date of registration: 29. November. 2024). It was approved by the Research Ethics Committee of the Second Affiliated Hospital of Xinxiang Medical University (Approval Code: XYEFYLL-2024-82, Approval Date: 6 November 2024). Recruitment began in December 2024.

Keywords: cognitive functions; music therapy; schizophrenia; study protocol; transcranial direct current stimulation.

Figure 1

Flowchart of the study design. This flowchart outlines the various stages of the study as well as the corresponding group assignments. The table provides a detailed list of the assessments conducted at different time points. BPRS, Brief Psychiatric Rating Scale; CGI, Clinical Global Impressions; fNIRS, Functional Near-Infrared Spectroscopy; MCCB, MATRICS Consensus Cognitive Battery; MT, music therapy; PANSS, Positive and Negative Syndrome Scale; SDSS, Social Dysfunction Screening Scale; SQLS, Schizophrenia Quality of Life Scale.

Figure 2

Study schedule for the participants in the randomized, double-blind, sham-controlled trial. fNIRS, Functional Near-Infrared Spectroscopy. MT, music therapy; tDCS, transcranial direct current stimulation.