Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment: a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area.

BACKGROUND: Chronic non-cancer pain (CNCP) treatment's primary goal is to maintain physical and mental functioning while improving quality of life. Opioid use in CNCP patients has increased in recent years, and non-pharmacological interventions such as music listening have been proposed to counter it. Unlike other auditive stimuli, music can activate emotional-regulating and reward-regulating circuits, making it a potential tool to modulate attentional processes and regulate mood. This study's primary objective is to provide the first evidence on the distinct (separate) effects of music listening as a coadjuvant maintenance analgesic treatment in CNCP patients undergoing opioid analgesia. METHODS AND ANALYSIS: This will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences.Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints' evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation. ETHICS AND DISSEMINATION: The study protocol has been reviewed, and ethics approval has been obtained from the Bellvitge University Hospital Institutional Review Board, L'Hospitalet de Llobregat, Barcelona, Spain. The results from this study will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05726266.

Putting music to trial: Consensus on key methodological challenges investigating music-based rehabilitation.

Major advances in music neuroscience have fueled a growing interest in music-based neurological rehabilitation among researchers and clinicians. Musical activities are excellently suited to be adapted for clinical practice because of their multisensory nature, their demands on cognitive, language, and motor functions, and music's ability to induce emotions and regulate mood. However, the overall quality of music-based rehabilitation research remains low to moderate for most populations and outcomes. In this consensus article, expert panelists who participated in the Neuroscience and Music VII conference in June 2021 address methodological challenges relevant to music-based rehabilitation research. The article aims to provide guidance on challenges related to treatment, outcomes, research designs, and implementation in music-based rehabilitation research. The article addresses how to define music-based rehabilitation, select appropriate control interventions and outcomes, incorporate technology, and consider individual differences, among other challenges. The article highlights the value of the framework for the development and evaluation of complex interventions for music-based rehabilitation research and the need for stronger methodological rigor to allow the widespread implementation of music-based rehabilitation into regular clinical practice.

Designing an app for home-based enriched Music-supported Therapy in the rehabilitation of patients with chronic stroke: a pilot feasibility study.

OBJECTIVE: After completing formal stroke rehabilitation programs, most patients do not achieve full upper limb motor function recovery. Music-supported Therapy (MST) can improve motor functionality post stroke through musical training. We designed a home-based enriched Music-supported Therapy (eMST) program to provide patients with chronic stroke the opportunity of continuing rehabilitation by themselves. We developed an app to conduct the eMST sessions at home with a MIDI-piano and percussion instruments. Here, we tested the feasibility of the eMST intervention using the novel app. METHOD: This is a pilot study where five patients with chronic stroke underwent a 10-week intervention of 3 sessions per week. Patients answered feasibility questionnaires throughout the intervention to modify aspects of the rehabilitation program and the app according to their feedback. Upper limb motor functions were evaluated pre- and post-intervention as well as speed and force tapping during daily piano performance. RESULTS: Patients clinically improved in upper limb motor function achieving the Minimal Detectable Change (MDC) or Minimal Clinically Important Difference (MCID) in most of motor tests. The app received high usability ratings post-intervention. CONCLUSION: The eMST program is a feasible intervention for patients with chronic stroke and its efficacy should be assessed in a clinical trial.

Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial.

BACKGROUND: Residual motor deficits of the upper limb in patients with chronic stroke are common and have a negative impact on autonomy, participation and quality of life. Music-Supported Therapy (MST) is an effective intervention to enhance motor and cognitive function, emotional well-being and quality of life in chronic stroke patients. We have adapted the original MST training protocol to a home-based intervention, which incorporates increased training intensity and variability, group sessions, and optimisation of learning to promote autonomy and motivation. METHODS: A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life of chronic stroke patients when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n = 30) or a control GRASP intervention group (n = 30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. DISCUSSION: We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov and identified as NCT04507542 on 8 August 2020.

Potential benefits of music playing in stroke upper limb motor rehabilitation.

Music-based interventions have emerged as a promising tool in stroke motor rehabilitation as they integrate most of the principles of motor training and multimodal stimulation. This paper aims to review the use of music in the rehabilitation of upper extremity motor function after stroke. First, we review the evidence supporting current music-based interventions including Music-supported Therapy, Music glove, group music therapy, Rhythm- and music-based intervention, and Musical sonification. Next, we describe the mechanisms that may be responsible for the effectiveness of these interventions, focusing on motor learning aspects, how multimodal stimulation may boost motor performance, and emotional and motivational aspects related to music. Then, we discuss methodological concerns in music therapy research related to modifications of therapy protocols, evaluation of patients and study designs. Finally, we highlight clinical considerations for the implementation of music-based interventions in clinical settings.

Enriching footsteps sounds in gait rehabilitation in chronic stroke patients: a pilot study.

In the context of neurorehabilitation, sound is being increasingly applied for facilitating sensorimotor learning. In this study, we aimed to test the potential value of auditory stimulation for improving gait in chronic stroke patients by inducing alterations of the frequency spectra of walking sounds via a sound system that selectively amplifies and equalizes the signal in order to produce distorted auditory feedback. Twenty-two patients with lower extremity paresis were exposed to real-time alterations of their footstep sounds while walking. Changes in body perception, emotion, and gait were quantified. Our results suggest that by altering footsteps sounds, several gait parameters can be modified in terms of left-right foot asymmetry. We observed that augmenting low-frequency bands or amplifying the natural walking sounds led to a reduction in the asymmetry index of stance and stride times, whereas it inverted the asymmetry pattern in heel-ground exerted force. By contrast, augmenting high-frequency bands led to opposite results. These gait changes might be related to updating of internal forward models, signaling the need for adjustment of the motor system to reduce the perceived discrepancies between predicted-actual sensory feedbacks. Our findings may have the potential to enhance gait awareness in stroke patients and other clinical conditions, supporting gait rehabilitation.

Music-supported therapy in the rehabilitation of subacute stroke patients: a randomized controlled trial.

The effect of music-supported therapy (MST) as a tool to restore hemiparesis of the upper extremity after a stroke has not been appropriately contrasted with conventional therapy. The aim of this trial was to test the effectiveness of adding MST to a standard rehabilitation program in subacute stroke patients. A randomized controlled trial was conducted in which patients were randomized to MST or conventional therapy in addition to the rehabilitation program. The intensity and duration of the interventions were equated in both groups. Before and after 4 weeks of treatment, motor and cognitive functions, mood, and quality of life (QoL) of participants were evaluated. A follow-up at 3 months was conducted to examine the retention of motor gains. Both groups significantly improved their motor function, and no differences between groups were found. The only difference between groups was observed in the language domain for QoL. Importantly, an association was encountered between the capacity to experience pleasure from music activities and the motor improvement in the MST group. MST as an add-on treatment showed no superiority to conventional therapies for motor recovery. Importantly, patient's intrinsic motivation to engage in musical activities was associated with better motor improvement.

Time course of motor gains induced by music-supported therapy after stroke: An exploratory case study.

OBJECTIVE: Previous studies have shown that Music-Supported Therapy (MST) can improve the motor function and promote functional neuroplastic changes in motor areas; however, the time course of motor gains across MST sessions and treatment periods remain unknown. The aim of this study was to explore the progression of the rehabilitation of motor deficits in a chronic stroke patient for a period of 7 months. METHOD: A reversal design (ABAB) was implemented in a chronic stroke patient where no treatment was provided in the A periods and MST was applied in the B periods. Each period comprised of 4 weeks and an extensive evaluation of the motor function using clinical motor tests and 3D movement analysis was performed weekly. During the MST periods, a keyboard task was recorded daily. A follow-up evaluation was performed 3 months after the second MST treatment. RESULTS: Improvements were observed during the first sessions in the keyboard task but clinical gains were noticeable only at the end of the first treatment and during the second treatment period. These gains were maintained in the follow-up evaluation. CONCLUSIONS: This is the first study examining the pattern of motor recovery progression in MST, evidencing that gradual and continuous motor improvements are possible with the repeated application of MST training. Fast-acquisition in specific motor abilities was observed at the beginning of the MST training but generalization of these improvements to other motor tasks took place at the end or when another treatment period was provided. (PsycINFO Database Record

Plasticity in the sensorimotor cortex induced by Music-supported therapy in stroke patients: a TMS study.

Playing a musical instrument demands the engagement of different neural systems. Recent studies about the musician's brain and musical training highlight that this activity requires the close interaction between motor and somatosensory systems. Moreover, neuroplastic changes have been reported in motor-related areas after short and long-term musical training. Because of its capacity to promote neuroplastic changes, music has been used in the context of stroke neurorehabilitation. The majority of patients suffering from a stroke have motor impairments, preventing them to live independently. Thus, there is an increasing demand for effective restorative interventions for neurological deficits. Music-supported Therapy (MST) has been recently developed to restore motor deficits. We report data of a selected sample of stroke patients who have been enrolled in a MST program (1 month intense music learning). Prior to and after the therapy, patients were evaluated with different behavioral motor tests. Transcranial Magnetic Stimulation (TMS) was applied to evaluate changes in the sensorimotor representations underlying the motor gains observed. Several parameters of excitability of the motor cortex were assessed as well as the cortical somatotopic representation of a muscle in the affected hand. Our results revealed that participants obtained significant motor improvements in the paretic hand and those changes were accompanied by changes in the excitability of the motor cortex. Thus, MST leads to neuroplastic changes in the motor cortex of stroke patients which may explain its efficacy.

Sensorimotor plasticity after music-supported therapy in chronic stroke patients revealed by transcranial magnetic stimulation.

BACKGROUND: Several recently developed therapies targeting motor disabilities in stroke sufferers have shown to be more effective than standard neurorehabilitation approaches. In this context, several basic studies demonstrated that music training produces rapid neuroplastic changes in motor-related brain areas. Music-supported therapy has been recently developed as a new motor rehabilitation intervention. METHODS AND RESULTS: In order to explore the plasticity effects of music-supported therapy, this therapeutic intervention was applied to twenty chronic stroke patients. Before and after the music-supported therapy, transcranial magnetic stimulation was applied for the assessment of excitability changes in the motor cortex and a 3D movement analyzer was used for the assessment of motor performance parameters such as velocity, acceleration and smoothness in a set of diadochokinetic movement tasks. Our results suggest that the music-supported therapy produces changes in cortical plasticity leading the improvement of the subjects' motor performance. CONCLUSION: Our findings represent the first evidence of the neurophysiological changes induced by this therapy in chronic stroke patients, and their link with the amelioration of motor performance. Further studies are needed to confirm our observations.