Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Post-stroke aphasia
Post-stroke neglect
Patients with disorders of consciusness (DOC)
Disqualifiers
No auditory injury
no hystory of neurological disease
No hystory of psychiatric disease
Previous stroke
Trial design
Design model
Parallel
Treatments tested in this trial
Combinatory effect of music stimulation and neurostimulation
Other interventionmusic
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Neuropsychological outcomes
-Coma Recovery Scale-Revised (CRS-R) - (0-23). High score means a better outcome.
Time frame
Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks2
Neuropsychological outcomes
Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.
Time frame
Change from baseline Disability Rating Scale at 2 weeks and 4 weeks3
Neuropsychological outcomes
Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.
Time frame
Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks4
Neuropsychological outcomes
Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.
Time frame
Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeksSecondary outcomes
1
Caregiver psychological distress
Back depression Inventory II (BDI II) - (0-63). High score means a worse outcome.
Time frame
Change from baseline Back depression Inventory II at 2 weeks and 4 weeks2
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.
Time frame
Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks3
Caregiver psychological distress
Psychophysiological Questionnaire (30-120). WHOQOL-BREF.
Time frame
Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks4
Caregiver psychological distress
Prolonged grief disorder -12 (PG-12) - (11-55). High score means a worse outcome.
Time frame
Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
University of Bari Aldo Moro
Collaborator
University of Aarhus
Collaborator
Source ClinicalTrials.gov