Clinical trial NCT05706831: Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases
Official title: Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Stroke
Keywords: music stimulation
tDCS
Aphasia
Neglect
DOC
Stroke
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: University of Bari Aldo Moro
name: University of Aarhus
First posted: 2023-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups of neurological patients will be considered for the study. For each group, participants will be randomly allocated to one of three intervention groups. These interventions will consist of a combination of musical stimulation, sham stimulation, tDCS and noise.
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Neuropsychological outcomes
timeFrame: Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Disability Rating Scale at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Barrage Test at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Letter cancellation test at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Sentence reading test at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline Wundt-Jastrow area illusion test at 2 weeks and 4 weeks
measure: Neuropsychological outcomes
timeFrame: Change from baseline The semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks and 4 weeks
measure: Neurophysiological outcome
timeFrame: Change from baseline oscillation at 2 weeks and 4 weeks
Secondary outcomes:
measure: Caregiver psychological distress
timeFrame: Change from baseline Back depression Inventory II at 2 weeks and 4 weeks
measure: Caregiver psychological distress
timeFrame: Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks
measure: Caregiver psychological distress
timeFrame: Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks
measure: Caregiver psychological distress
timeFrame: Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeks
measure: Caregiver psychological distress
timeFrame: Change from baseline Family strain questionnaire at 2 weeks and 4 weeks
measure: Caregiver psychological distress
timeFrame: Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Ba
Study officials:
References: