Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases
NCT ID: NCT05706831
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2022-09-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Describing the Effect of Familiar Song on Arousal and Awareness for Children With Disorders of Consciousness (DoC)
NCT07209657
tDCS and Musical Performance in Young Orchestra Musicians
NCT06958081
Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)
NCT03281330
Effectiveness of Music Therapy on Level of Consciousness
NCT04442971
Rhythmic Auditory Stimulation & Gait Training
NCT04314076
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Group 1 will receive tEs combined with music stimulation for 2 weeks, 1 week of wash out, then sham stimulation combined with noise (placebo) for other 2 weeks.
Combinatory effect of music stimulation and neurostimulation
music
Group 2
Group 2 will receive sham stimulation and noise (placebo) for the first 2 weeks, then 1 week wash out, and finally tEs and music stimulation for other 2 weeks.
Combinatory effect of music stimulation and neurostimulation
music
Group 3
Group 3 will receive only music stimulation and sham stimulation for 2 weeks, 1 week of wash out, then sham stimulation and noise (placebo) for another 2 weeks.
Combinatory effect of music stimulation and neurostimulation
music
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Combinatory effect of music stimulation and neurostimulation
music
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Post-stroke aphasia
* Post-stroke neglect
* Patients with disorders of consciusness (DOC)
Exclusion Criteria
* no hystory of neurological disease
* No hystory of psychiatric disease
* Previous stroke
* use of alcohol and drugs
* premorbid dementia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bari Aldo Moro
OTHER
University of Aarhus
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Simona Spaccavento
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istituti Clinici Scientifici Maugeri
Bari, Ba, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Simona Spaccavento
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
345
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.