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Recruiting
NCT05706831
Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases
Conditions: Disorder of Consciousness, Stroke
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 90
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Location: Italy
Summary
The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients.
The main questions it aims to answer are:to evaluate the residual neuroplastic processes in DOC state related to music exposureto determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulationto evaluate the impact of this intervention on caregiver's burden and psychological distress.Participants will be randomly assigned to one of three different music-listening intervention groups.
Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.
Eligibility Criteria
Inclusion Criteria:Age > 18 yearsPost-stroke aphasiaPost-stroke neglectPatients with disorders of consciusness (DOC)Exclusion Criteria:No auditory injuryno hystory of neurological diseaseNo hystory of psychiatric diseasePrevious strokeuse of alcohol and drugspremorbid dementia
Source: ClinicalTrials.gov (NCT05706831). StuddyBuddy aggregates publicly available trial information.