Disorder of Consciousness, Stroke
Conditions
Keywords
music stimulation, tDCS, Aphasia, Neglect, DOC, Stroke
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.
Interventions
OTHERCombinatory effect of music stimulation and neurostimulation
music
Sponsors
University of Bari Aldo Moro
University of Aarhus
Istituti Clinici Scientifici Maugeri SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver psychological distress | 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. |
Countries
Italy
Contacts
Primary ContactSimona Spaccavento
Outcome results
None listed