Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Stroke Clinical Trial

Official title:

Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706831
• Other study ID #: 345
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Simona Spaccavento
• Phone: +393332783524
• Email: simona.spaccavento[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Nervous System Diseases
• Stroke

Intervention

Other:
• Combinatory effect of music stimulation and neurostimulation
music

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri	Bari	Ba

Sponsors (3)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	University of Aarhus, University of Bari Aldo Moro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Neuropsychological outcomes	Barrage test (0-36). High score means a better outcome.	Change from baseline Barrage Test at 2 weeks and 4 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Neurophysiological outcome	The ratio of fast (8-30 Hz, a-ß) to slow (2-8 Hz, d-?) 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	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
Secondary	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
Secondary	Caregiver psychological distress	Psychophysiological Questionnaire (30-120). WHOQOL-BREF.	Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks
Secondary	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
Secondary	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
Secondary	Caregiver psychological distress	better outcome.	Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks