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NCT Number: NCT05706831

Music Intervention and Transcranial Electrical Stimulation for 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.

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Key information

Conditions

Disorder of Consciousness Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Consciousness Disorders Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituti Clinici Scientifici Maugeri

Bari, Ba, 70025, Italy

Location status: Recruiting

Location contact

Simona Spaccavento

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combinatory effect of music stimulation and neurostimulation

Other

music

Primary outcomes

  1. Neuropsychological outcomes

    Time frame: Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks

    -Coma Recovery Scale-Revised (CRS-R) - (0-23). High score means a better outcome.

  2. Neuropsychological outcomes

    Time frame: Change from baseline Disability Rating Scale at 2 weeks and 4 weeks

    Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.

  3. Neuropsychological outcomes

    Time frame: Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks

    Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.

  4. Neuropsychological outcomes

    Time frame: Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks

    Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.

  5. Neuropsychological outcomes

    Time frame: Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks

    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).

  6. Neuropsychological outcomes

    Time frame: Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks

    Italian version of Functional Outcome Questionnaire for Aphasie (FOQ-A) - (32-160). High score means a better outcome.

  7. Neuropsychological outcomes

    Time frame: Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks

    Functional Assessment Measure - Cognitive subscale - (FAM) - (14-98); high score means a better outcome.

  8. Neuropsychological outcomes

    Time frame: Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks

    Quality of Life questionnaire for Aphasics (QLQA) - (0-148); High score means a better outcome.

  9. Neuropsychological outcomes

    Time frame: Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks

    The semi-structured scale for functional evaluation of personal neglect - (0-9); High score means a worse outcome.

  10. Neuropsychological outcomes

    Time frame: Change from baseline Barrage Test at 2 weeks and 4 weeks

    Barrage test (0-36). High score means a better outcome.

  11. Neuropsychological outcomes

    Time frame: Change from baseline Letter cancellation test at 2 weeks and 4 weeks

    Letter cancellation test - (0-104). High score means a better outcome.

  12. Neuropsychological outcomes

    Time frame: Change from baseline Sentence reading test at 2 weeks and 4 weeks

    Sentence reading test (0-6). High score means a worse outcome.

  13. Neuropsychological outcomes

    Time frame: Change from baseline Wundt-Jastrow area illusion test at 2 weeks and 4 weeks

    Wundt-Jastrow area illusion test (0-20). High score means a worse outcome.

  14. Neuropsychological outcomes

    Time frame: Change from baseline The semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks and 4 weeks

    The semi structured scale for the functional evaluation of extrapersonal neglect (0-9). High score means a worse outcome.

  15. Neurophysiological outcome

    Time frame: Change from baseline oscillation at 2 weeks and 4 weeks

    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."

Secondary outcomes

  1. Caregiver psychological distress

    Time frame: Change from baseline Back depression Inventory II at 2 weeks and 4 weeks

    Back depression Inventory II (BDI II) - (0-63). High score means a worse outcome.

  2. Caregiver psychological distress

    Time frame: Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks

    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.

  3. Caregiver psychological distress

    Time frame: Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks

    Psychophysiological Questionnaire (30-120). WHOQOL-BREF.

  4. Caregiver psychological distress

    Time frame: Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeks

    Prolonged grief disorder -12 (PG-12) - (11-55). High score means a worse outcome.

  5. Caregiver psychological distress

    Time frame: Change from baseline Family strain questionnaire at 2 weeks and 4 weeks

    Family strain questionnaire (FSQ) - (1-44). High score means a worse outcome.

  6. Caregiver psychological distress

    Time frame: Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks

    better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Simona Spaccavento

CONTACT

[email protected]

+393332783524

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • University of Aarhus
  • University of Bari Aldo Moro

Registry information

Official study title

Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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