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Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases

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What is being tested

Combinatory effect of music stimulation and neurostimulation

Other
Who is being recruted

Aphasia+15

+ Mental Disorders

+ Brain Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2022
See protocol details

Summary

Principal SponsorIstituti Clinici Scientifici Maugeri SpA
Study ContactSimona Spaccavento
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2022

Actual date on which the first participant was enrolled.

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 exposure * to 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 stimulation * to 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.

Official TitleMusic Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases
NCT05706831
Principal SponsorIstituti Clinici Scientifici Maugeri SpA
Study ContactSimona Spaccavento
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AphasiaMental DisordersBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersCommunication DisordersConsciousness DisordersLanguage DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsSpeech DisordersPathological Conditions, Signs and SymptomsVascular DiseasesNeurobehavioral ManifestationsNeurocognitive DisordersStroke

Criteria

4 inclusion criteria required to participate
Post-stroke aphasia
Post-stroke neglect
Age > 18 years
Patients with disorders of consciusness (DOC)
6 exclusion criteria prevent from participating
No auditory injury
no hystory of neurological disease
No hystory of psychiatric disease
Previous stroke
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group 1 will receive tEs combined with music stimulation for 2 weeks, 1 week of wash out, then sham stimulation combined with noise (placebo) for other 2 weeks.

Group II

Experimental
Group 2 will receive sham stimulation and noise (placebo) for the first 2 weeks, then 1 week wash out, and finally tEs and music stimulation for other 2 weeks.

Group III

Experimental
Group 3 will receive only music stimulation and sham stimulation for 2 weeks, 1 week of wash out, then sham stimulation and noise (placebo) for another 2 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Istituti Clinici Scientifici Maugeri

Bari, ItalyOpen Istituti Clinici Scientifici Maugeri in Google Maps
Recruiting
One Study Center