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Recruiting NCT05706831

Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

No phase Interventional Disorder of Consciousness Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combinatory effect of music stimulation and neurostimulation.
Who it may be relevant to
Registry conditions: Disorder of Consciousness, Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases

Overview

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

  • Other Combinatory effect of music stimulation and neurostimulation
    music

Primary outcome measures

  • Neuropsychological outcomes [Time frame: Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Disability Rating Scale at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks]
  • Neuropsychological outcomes [Time frame: Change from baseline Barrage Test at 2 weeks and 4 weeks]
Secondary outcome measures (6)
  • Caregiver psychological distress [Time frame: Change from baseline Back depression Inventory II at 2 weeks and 4 weeks]
  • Caregiver psychological distress [Time frame: Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks]
  • Caregiver psychological distress [Time frame: Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks]
  • Caregiver psychological distress [Time frame: Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeks]
  • Caregiver psychological distress [Time frame: Change from baseline Family strain questionnaire at 2 weeks and 4 weeks]
  • Caregiver psychological distress [Time frame: Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Istituti Clinici Scientifici Maugeri — Bari

Publications

  • Spaccavento S, Carraturo G, Brattico E, Matarrelli B, Rivolta D, Montenegro F, Picciola E, Haumann NT, Jespersen KV, Vuust P, Losavio E. Musical and electrical stimulation as intervention in disorder of consciousness (DOC) patients: A randomised cross-over trial. PLoS One. 2024 May 31;19(5):e0304642. doi: 10.1371/journal.pone.0304642. eCollection 2024. PMID 38820520

Identifiers

NCT: NCT05706831 · 345

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗