Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Condition(s) studied

Investigational drug(s) / intervention(s)

Combinatory effect of music stimulation and neurostimulation: music

Study 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.

Eligibility

Primary outcome measure(s)

• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — Change from baseline Disability Rating Scale at 2 weeks and 4 weeks
  Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.
• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — 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).
• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — Change from baseline Barrage Test at 2 weeks and 4 weeks
  Barrage test (0-36). High score means a better outcome.
• Neuropsychological outcomes — Change from baseline Letter cancellation test at 2 weeks and 4 weeks
  Letter cancellation test - (0-104). High score means a better outcome.
• Neuropsychological outcomes — Change from baseline Sentence reading test at 2 weeks and 4 weeks
  Sentence reading test (0-6). High score means a worse outcome.
• Neuropsychological outcomes — 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.
• Neuropsychological outcomes — 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.
• Neurophysiological outcome — 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."

Trial sites (1)

More Istituti Clinici Scientifici Maugeri SpA trials in Italy

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