Feasibility Trial Protocol for a Remote Intentional Music Listening Intervention to Support Mental Health in Individuals with Chronic Stroke.

INTRODUCTION

Post-stroke depression affects approximately 30% of stroke survivors and is linked to worse functional outcomes, cognitive decline, reduced quality of life, and increased mortality. While early treatment of post-stroke mental health conditions is critical, current pharmacological options offer limited efficacy. Music listening interventions are a promising, low-risk, accessible, and affordable alternative that may enhance recovery through engagement of reward-related brain circuits. However, most music listening studies have focused on the acute stage of stroke, lack objective measures of music engagement, and rarely assess underlying neural mechanisms. To address these gaps, we propose a feasibility study of a remotely delivered music-listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural, and physiological changes.

METHODS AND ANALYSIS

We will conduct a parallel group randomized controlled feasibility trial enrolling 60 patients with chronic stroke from a well-characterized stroke registry in New York City. Participants will be randomized to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week pre-intervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (i.e., track identity, duration, and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioral outcomes related to mental health will be assessed at baseline, pre-intervention, post-intervention, and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity, and heart rate) will be collected pre- and post-intervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, treatment fidelity, feasibility, acceptability, and participant burden. Secondary outcomes include recruitment and randomization rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for post-stroke mental health recovery.

ETHICS AND DISSEMINATION

The study was approved by New York University's Institutional Review Board (FY2024-8826). All human participants will provide written informed consent prior to participation and will be adequately compensated for their time. Results will be reported in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT07127159 ( ClinicalTrials.gov ).

ARTICLE SUMMARY

Access to a large, diverse, and well-characterized population of chronic stroke patients from the greater New York City area.Use of a digital platform for intervention delivery and collection of experience sampling and digital phenotyping data.Use of multi-modal methods, including an objective measure of treatment dose, to assess the effect of the intervention (behavior, physiology, neuroimaging).Limited power to assess mental health, cognitive, and brain plasticity effects of the intervention; the primary focus of the study is to determine feasibility.Limited generalizability as this is a single-center study.