Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Disorder of Consciousness
• Intervention / Treatment: Other: Combinatory effect of music stimulation and neurostimulation

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simona Spaccavento; Phone Number: +393332783524; Email: simona.spaccavento@icsmaugeri.it

Study Locations

• Italy
  • Ba
    • Bari, Ba, Italy, 70025
      • Recruiting
      • Istituti Clinici Scientifici Maugeri
      • Contact: Simona Spaccavento

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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.	Other: Combinatory effect of music stimulation and neurostimulation; music
Experimental: Group 2; 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.	Other: Combinatory effect of music stimulation and neurostimulation; music
Experimental: Group 3; 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.	Other: Combinatory effect of music stimulation and neurostimulation; music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychological outcomes	-Coma Recovery Scale-Revised (CRS-R) - (0-23). High score means a better outcome.	Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks
Neuropsychological outcomes	Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.	Change from baseline Disability Rating Scale at 2 weeks and 4 weeks
Neuropsychological outcomes	Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.	Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks
Neuropsychological outcomes	Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.	Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks
Neuropsychological outcomes	Aachener Aphasie Test (AAT). This test includes six subtests: spontaneous speech, token test, repetition, written language, naming, and comprehension. Spontaneous speech is structured in six parts (0-30). High score means a better performance; Token test is composed by 50 items; for the score the number of error id considered (0-50). Repetition sub test is composed by 50 items; for each item the score range from 0 to 3; high score means better outcome (0-150). Written language subtest is composed by 30 items; for each item the score range from 0 to 3; high score means better outcome (0-90). Naming subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120). Comprehension subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120).	Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks
Neuropsychological outcomes	Italian version of Functional Outcome Questionnaire for Aphasie (FOQ-A) - (32-160). High score means a better outcome.	Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks
Neuropsychological outcomes	Functional Assessment Measure - Cognitive subscale - (FAM) - (14-98); high score means a better outcome.	Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks
Neuropsychological outcomes	Quality of Life questionnaire for Aphasics (QLQA) - (0-148); High score means a better outcome.	Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks
Neuropsychological outcomes	The semi-structured scale for functional evaluation of personal neglect - (0-9); High score means a worse outcome.	Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks
Neuropsychological outcomes	Barrage test (0-36). High score means a better outcome.	Change from baseline Barrage Test at 2 weeks and 4 weeks
Neuropsychological outcomes	Letter cancellation test - (0-104). High score means a better outcome.	Change from baseline Letter cancellation test at 2 weeks and 4 weeks
Neuropsychological outcomes	Sentence reading test (0-6). High score means a worse outcome.	Change from baseline Sentence reading test at 2 weeks and 4 weeks
Neuropsychological outcomes	Wundt-Jastrow area illusion test (0-20). High score means a worse outcome.	Change from baseline Wundt-Jastrow area illusion test at 2 weeks and 4 weeks
Neuropsychological outcomes	The semi structured scale for the functional evaluation of extrapersonal neglect (0-9). High score means a worse outcome.	Change from baseline The semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks and 4 weeks
Neurophysiological outcome	The ratio of fast (8-30 Hz, α-β) to slow (2-8 Hz, δ-θ) oscillation amplitude at the midline electrodes (Fz, Cz, Pz, Oz) will be measured and compared pre- and post intervention."	Change from baseline oscillation at 2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver psychological distress	Back depression Inventory II (BDI II) - (0-63). High score means a worse outcome.	Change from baseline Back depression Inventory II at 2 weeks and 4 weeks
Caregiver psychological distress	State-trait anxiety inventory (STAI-Y). It is composed by two scales: STAI-Y State (20-80) and STAI-Y Trait (20-80). High score means a worse outcome.	Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks
Caregiver psychological distress	Psychophysiological Questionnaire (30-120). WHOQOL-BREF.	Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks
Caregiver psychological distress	Prolonged grief disorder -12 (PG-12) - (11-55). High score means a worse outcome.	Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeks
Caregiver psychological distress	Family strain questionnaire (FSQ) - (1-44). High score means a worse outcome.	Change from baseline Family strain questionnaire at 2 weeks and 4 weeks
Caregiver psychological distress	better outcome.	Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: University of Aarhus; University of Bari Aldo Moro

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: tDCS; Stroke; Aphasia; Neglect; DOC; music stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Nervous System Diseases; Consciousness Disorders
• Other Study ID Numbers: 345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No