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Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Not Applicable
Recruiting
Conditions
Stroke
Disorder of Consciousness
Registration Number
NCT05706831
Lead Sponsor
Istituti Clinici Scientifici Maugeri SpA
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Neuropsychological outcomesChange 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 outcomeChange 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 Outcome Measures
NameTimeMethod
Caregiver psychological distressChange from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks

better outcome.

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri

🇮🇹

Bari, Ba, Italy

Istituti Clinici Scientifici Maugeri
🇮🇹Bari, Ba, Italy
Simona Spaccavento
Contact

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