Disorder of ConsciousnessNCT05706831
Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases
A study testing Combinatory effect of music stimulation and neurostimulation in people with Disorder of Consciousness and Stroke, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness, Stroke
- What is being tested?
- Combinatory effect of music stimulation and neurostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Post-stroke aphasia
- Post-stroke neglect
- Patients with disorders of consciusness (DOC)
Who cannot join
- No auditory injury
- no hystory of neurological disease
- No hystory of psychiatric disease
- Previous stroke
- use of alcohol and drugs
- premorbid dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri
Bari, Ba, 70025
Simona Spaccavento
About this study
Official title: Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases
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.
- Conditions
- Disorder of Consciousness, Stroke
- Being tested
- Combinatory effect of music stimulation and neurostimulation
- Keywords
- music stimulation, tDCS, Aphasia, Neglect, DOC, Stroke
- Medical subject headings
- Consciousness Disorders, Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combinatory effect of music stimulation and neurostimulationOther
music
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Other: Combinatory effect of music stimulation and neurostimulation |
| Group 2 | Experimental | 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. Receives: Other: Combinatory effect of music stimulation and neurostimulation |
| Group 3 | Experimental | 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. Receives: Other: Combinatory effect of music stimulation and neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological outcomes
-Coma Recovery Scale-Revised (CRS-R) - (0-23). High score means a better outcome.
Measured: Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks
Neuropsychological outcomes
Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.
Measured: Change from baseline Disability Rating Scale at 2 weeks and 4 weeks
Neuropsychological outcomes
Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.
Measured: Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks
Neuropsychological outcomes
Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.
Measured: Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks
Neuropsychological outcomes
Aachener Aphasie Test (AAT). This test includes six subtests: spontaneous speech, token test, repetition, written language, naming, and comprehension.
Spontaneous speech is structured in six parts (0-30). High score means a better performance; Token test is composed by 50 items; for the score the number of error id considered (0-50).
Repetition sub test is composed by 50 items; for each item the score range from 0 to 3; high score means better outcome (0-150).
Written language subtest is composed by 30 items; for each item the score range from 0 to 3; high score means better outcome (0-90).
Naming subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120).
Comprehension subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120).
Measured: Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks
Neuropsychological outcomes
Italian version of Functional Outcome Questionnaire for Aphasie (FOQ-A) - (32-160). High score means a better outcome.
Measured: Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks
Neuropsychological outcomes
Functional Assessment Measure - Cognitive subscale - (FAM) - (14-98); high score means a better outcome.
Measured: Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks
Neuropsychological outcomes
Quality of Life questionnaire for Aphasics (QLQA) - (0-148); High score means a better outcome.
Measured: Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks
Neuropsychological outcomes
The semi-structured scale for functional evaluation of personal neglect - (0-9); High score means a worse outcome.
Measured: Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks
Neuropsychological outcomes
Barrage test (0-36). High score means a better outcome.
Measured: Change from baseline Barrage Test at 2 weeks and 4 weeks
Neuropsychological outcomes
Letter cancellation test - (0-104). High score means a better outcome.
Measured: Change from baseline Letter cancellation test at 2 weeks and 4 weeks
Neuropsychological outcomes
Sentence reading test (0-6). High score means a worse outcome.
Measured: Change from baseline Sentence reading test at 2 weeks and 4 weeks
Neuropsychological outcomes
Wundt-Jastrow area illusion test (0-20). High score means a worse outcome.
Measured: Change from baseline Wundt-Jastrow area illusion test at 2 weeks and 4 weeks
Neuropsychological outcomes
The semi structured scale for the functional evaluation of extrapersonal neglect (0-9). High score means a worse outcome.
Measured: Change from baseline The semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks and 4 weeks
Neurophysiological outcome
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."
Measured: Change from baseline oscillation at 2 weeks and 4 weeks
Secondary outcomes (6)
Caregiver psychological distress
Back depression Inventory II (BDI II) - (0-63). High score means a worse outcome.
Measured: Change from baseline Back depression Inventory II at 2 weeks and 4 weeks
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.
Measured: Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks
Caregiver psychological distress
Psychophysiological Questionnaire (30-120). WHOQOL-BREF.
Measured: Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks
Caregiver psychological distress
Prolonged grief disorder -12 (PG-12) - (11-55). High score means a worse outcome.
Measured: Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeks
Caregiver psychological distress
Family strain questionnaire (FSQ) - (1-44). High score means a worse outcome.
Measured: Change from baseline Family strain questionnaire at 2 weeks and 4 weeks
Caregiver psychological distress
better outcome.
Measured: Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro, University of Aarhus
- Responsible party
- Principal investigator, Simona Spaccavento, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706831
- Sponsor's protocol ID
- 345
- Status last verified
- Apr 2025
- First submitted
- 16 Nov 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38820520
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases
- ClinicalTrials.gov ID
- NCT05706831
- Acronym / sponsor ID
- 345
- Conditions
- Disorder of Consciousness, Stroke
- Keywords
- music stimulation, tDCS, Aphasia, Neglect, DOC, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- University of Bari Aldo Moro, University of Aarhus
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Combinatory effect of music stimulation and neurostimulationGroup 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. |
| Group 2 | Experimental | Other: Combinatory effect of music stimulation and neurostimulationGroup 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. |
| Group 3 | Experimental | Other: Combinatory effect of music stimulation and neurostimulationGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Post-stroke aphasia
- Post-stroke neglect
- Patients with disorders of consciusness (DOC)
Key exclusion criteria (6 listed)
- No auditory injury
- no hystory of neurological disease
- No hystory of psychiatric disease
- Previous stroke
- use of alcohol and drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combinatory effect of music stimulation and neurostimulationmusic | Other | Group 1, Group 2, Group 3 |
Primary outcome
Neuropsychological outcomes
Time frame: 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.
Neuropsychological outcomes
Time frame: Change from baseline Disability Rating Scale at 2 weeks and 4 weeks
Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.
Neuropsychological outcomes
Time frame: Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks
Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.
Neuropsychological outcomes
Time frame: Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks
Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.
Neuropsychological outcomes
Time frame: Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks
Aachener Aphasie Test (AAT). This test includes six subtests: spontaneous speech, token test, repetition, written language, naming, and comprehension. Spontaneous speech is structured in six parts (0-30). High score means a better performance; Token test is composed by 50 items; for the score the number of error id considered (0-50). Repetition sub test is composed by 50 items; for each item the score range from 0 to 3; high score means better outcome (0-150). Written language subtest is composed by 30 items; for each item the score range from 0 to 3; high score means better outcome (0-90). Naming subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120). Comprehension subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120).
Neuropsychological outcomes
Time frame: Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks
Italian version of Functional Outcome Questionnaire for Aphasie (FOQ-A) - (32-160). High score means a better outcome.
Neuropsychological outcomes
Time frame: Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks
Functional Assessment Measure - Cognitive subscale - (FAM) - (14-98); high score means a better outcome.
Neuropsychological outcomes
Time frame: Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks
Quality of Life questionnaire for Aphasics (QLQA) - (0-148); High score means a better outcome.
Neuropsychological outcomes
Time frame: Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks
The semi-structured scale for functional evaluation of personal neglect - (0-9); High score means a worse outcome.
Neuropsychological outcomes
Time frame: Change from baseline Barrage Test at 2 weeks and 4 weeks
Barrage test (0-36). High score means a better outcome.
Neuropsychological outcomes
Time frame: Change from baseline Letter cancellation test at 2 weeks and 4 weeks
Letter cancellation test - (0-104). High score means a better outcome.
Neuropsychological outcomes
Time frame: Change from baseline Sentence reading test at 2 weeks and 4 weeks
Sentence reading test (0-6). High score means a worse outcome.
Neuropsychological outcomes
Time frame: Change from baseline Wundt-Jastrow area illusion test at 2 weeks and 4 weeks
Wundt-Jastrow area illusion test (0-20). High score means a worse outcome.
Neuropsychological outcomes
Time frame: Change 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 outcome
Time frame: 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."
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 38820520Spaccavento 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.
Related trials for Disorder of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combinatory effect of music stimulation and neurostimulation in people with Disorder of Consciousness and Stroke, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simona Spaccavento (+393332783524, simona.spaccavento@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological outcomes (time frame: Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.