RecruitingNCT05706831ClinicalTrials.gov record

Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Disorder of Consciousness · Stroke

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 90 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Double masked

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

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

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

Combinatory effect of music stimulation and neurostimulation OTHER

music

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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."