Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Stroke; Disorder of Consciousness

Treatments: Other: Combinatory effect of music stimulation and neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05706831

345

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Post-stroke aphasia
• Post-stroke neglect
• Patients with disorders of consciusness (DOC)

Exclusion criteria

• No auditory injury
• no hystory of neurological disease
• No hystory of psychiatric disease
• Previous stroke
• use of alcohol and drugs
• premorbid dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Other: Combinatory effect of music stimulation and neurostimulation

Group 2

Experimental group

Description:

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.

Treatment:

Other: Combinatory effect of music stimulation and neurostimulation

Group 3

Experimental group

Description:

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.

Treatment:

Other: Combinatory effect of music stimulation and neurostimulation