Post StrokeML4STROKENCT07432204
Therapeutic Music Listening in Post Stroke Patients.
A study testing Music intervention in people with Post Stroke and Anxiety, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Numerous studies have highlighted how individualized music listening favors motor, cognitive, and emotional recovery in post-stroke patients, stimulating neuroplasticity and cerebral connectivity. However, gaps persist regarding the standardization of protocols and the neural mechanisms involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke, Anxiety, Depression
- What is being tested?
- Music intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2025to 31 Dec 2027
- 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
- Diagnosis of first ischemic or hemorrhagic stroke verified by Computerized Axial Tomography or Magnetic Resonance
- Age above 18 years
- Mini Mental State Examination ≥ 24
- Latency from the event < 3 months
- Presence of clinically significant anxiety and/or depression (Generalized Anxiety Disorder and/or Patient Health Questionnaire ≥10)
- Onset of acute event not more than 90 days prior to enrollment in the study
Who cannot join
- Clinical instability
- Lesions dated over 3 months from onset
- Multiple or bilateral lesions
- Mini Mental State Examination < 24
- Previous or concomitant neurological, psychiatric, or internal pathologies found in the year preceding the study that, in the judgment of the clinical investigator, may affect the psychological condition and/or interfere with study procedures
- Behavioral/cognitive disorders that prevent adequate patient compliance with treatment
Show all 12Show fewer
- Therapeutic-rehabilitative treatments with music in the year preceding the study
- Previous musical skills (training or musical practice lasting more than 3 years)
- Refusal or impossibility to sign informed consent
- For the subgroup of patients subjected to functional Magnetic Resonance, the following exclusion criteria will also be taken into account:
- Incompatibility with the execution of the MRI investigation (e.g., ascertained or possible presence of metal in the body; claustrophobia; sickle cell anemia)
- Inability to understand or provide informed consent for the execution of the MRI investigation
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
Fondazione Salvatore Maugeri I.R.C.C.S.
Pavia, 27100
Alfredo Raglio, +39 03825921, alfredo.raglio@icsmaugeri.it
About this study
Official title: Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.
Numerous studies have highlighted how individualized music listening favors motor, cognitive, and emotional recovery in post-stroke patients, stimulating neuroplasticity and cerebral connectivity. However, gaps persist regarding the standardization of protocols and the neural mechanisms involved. This study aims to bridge these gaps with a rigorous scientific approach, integrating clinical assessments and neuroimaging.
This is a multicenter randomized controlled single-blind trial. Subjects will be allocated into 2 groups: an experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care), and a control group subjected solely to conventional therapeutic interventions (standard care). A follow-up is scheduled for one month after the conclusion of treatment. The study duration is 24 months and the screening phase will be continuous until the conclusion of planned recruitment.
Read more
Primary objective of the study is to evaluate the efficacy of Therapeutic Music Listening (TML) on anxiety in post-stroke patients.
Secondary objective of the study is to investigate other possible effects on depression, quality of life, cognitive aspects (specifically attention and memory), and on connectivity via functional Magnetic Resonance Imaging (fMRI).
Primary endpoint is the reduction of anxiety. Secondary endpoint is the improvement in depression, quality of life, cognitive functions, and cerebral connectivity parameters.
- Conditions
- Post Stroke, Anxiety, Depression
- Being tested
- Music intervention, Control group
- Keywords
- Therapeutic Music Listening, Stroke, Anxiety, Depression, Neuroplasticity, fMRI, Cognitive functions, Connectivity
- Medical subject headings
- Anxiety Disorders, Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
Also called Therapeutic Music Listening
The intervention will be managed by a professional music therapist with the collaboration of an operator. The music therapist collects data on the clinical history and musical preferences of the patient, which are integrated with the use of specific musical parameters and structures to create personalized playlists lasting 40 minutes. Such playlists aim to reflect the musical tastes of the patient and at the same time to obtain therapeutic objectives inducing relaxation, activation or distraction, depending on the clinical needs. The listening sessions take place daily for one month at a time of day chosen with the patient, who listen to the playlist through the use of a tablet and headphones. The music therapist submits to the patient a brief questionnaire after the first listening and then weekly, to verify the impact of music listening and possibly modify the playlist in line with the patient's feedback and the evolution of the treatment.
Control groupOther
Standard treatment is based on daily rehab activities (physical therapy and/or occupational therapy) and weekly psychological support sessions.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Music Listening intervention | Experimental | Experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care) Receives: Other: Music intervention |
| Control group | Experimental | Control group subjected solely to conventional therapeutic interventions. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Therapeutic Music Listening (TML) on anxiety in post stroke patients
To evaluate the impact of Therapeutic Music Listening on the improvement of anxiety, that will be measured using the Generalized Anxiety Disorder scale (GAD-7). In this scale scores range from 0 to 21 with higher scores indicating more severe GAD symptoms.
Measured: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
Effectiveness of Therapeutic Music Listening (TML) on depression in post stroke patients
To evaluate the impact of Therapeutic Music Listening on the improvement of depression, that will be measured using the Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 with higher scores indicating more severe PHQ symptoms.
Measured: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
Effectiveness of Therapeutic Music Listening (TML) on quality of life in post stroke patients
To evaluate the impact of Therapeutic Music Listening on the improvement of quality of life, that will be measured using the EuroQol-5D (EQ-5D). Scores are of two types: the Utility Index (EQ-5D Index), that represents the ratio between health state and social utility, and the Visual Analogue Scale (EQ-VAS) that represents the subjective self-perception of health. The EQ-5D Index ranges from 0.000 to 1.000 with the latter indicating "full health" and the EQ-VAS ranges from 0 to 100 with the latter indicating the best state of health.
Measured: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
Effectiveness of Therapeutic Music Listening (TML) on cognitive outcomes in post stroke patients
To evaluate the impact of Therapeutic Music Listening on the improvement of cognitive outocomes (with particular focus on Memory and Attention), that will be measured using the Monteral Cognitive Assessment (MoCA). Scores range from 0 to 30 with scores of 26 or above considered normal.
Measured: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
Secondary outcomes (2)
fMRI investigation on the resting-state brain activity modifications
The main variable regarding resting-state brain activity will be the activation intensity within each individual voxel of the magnetic resonance images, inferred as a metric of functional connectivity between the Blood Oxygen Level Dependent (BOLD) contrast signal time series in each image voxel. This variable will consist of distinct intrinsic connectivity metrics, specifically: a) "seed-to-voxel" connectivity originating from auditory brain areas; b) connectivity between "resting-state networks" identified via multivariate analysis methods of the resting-state fMRI data.
Measured: From enrollment to end of treatment at 4 weeks.
fMRI investigation on the brain macrostructure modifications
The main variable regarding brain macrostructure will be the contrast index between gray matter and white matter within each individual voxel of the magnetic resonance images (T1-weighted). The pre-processing and statistical analysis of these images will provide an index related to gray matter volume and density within each individual voxel.
Measured: From enrollment to end of treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start12 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post StrokeStudies 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
- Multicenter randomized controlled single-blind trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Armonica Onlus Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432204
- Sponsor's protocol ID
- ML4STROKE-CTSM179-25
- Acronym
- ML4STROKE
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07432204
- Acronym / sponsor ID
- ML4STROKE / ML4STROKE-CTSM179-25
- Conditions
- Post Stroke, Anxiety, Depression
- Keywords
- Therapeutic Music Listening, Stroke, Anxiety, Depression, Neuroplasticity, fMRI, Cognitive functions, Connectivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Armonica Onlus Foundation
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Feb 2026 (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.
Numerous studies have highlighted how individualized music listening favors motor, cognitive, and emotional recovery in post-stroke patients, stimulating neuroplasticity and cerebral connectivity. However, gaps persist regarding the standardization of protocols and the neural mechanisms involved. This study aims to bridge these gaps with a rigorous scientific approach, integrating clinical assessments and neuroimaging.
This is a multicenter randomized controlled single-blind trial. Subjects will be allocated into 2 groups: an experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care), and a control group subjected solely to conventional therapeutic interventions (standard care). A follow-up is scheduled for one month after the conclusion of treatment. The study duration is 24 months and the screening phase will be continuous until the conclusion of planned recruitment.
Primary objective of the study is to evaluate the efficacy of Therapeutic Music Listening (TML) on anxiety in post-stroke patients.
Secondary objective of the study is to investigate other possible effects on depression, quality of life, cognitive aspects (specifically attention and memory), and on connectivity via functional Magnetic Resonance Imaging (fMRI).
Primary endpoint is the reduction of anxiety. Secondary endpoint is the improvement in depression, quality of life, cognitive functions, and cerebral connectivity parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled single-blind trial
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Music Listening intervention | Experimental | Other: Music interventionExperimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care) |
| Control group | Experimental | Other: Control groupControl group subjected solely to conventional therapeutic interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of first ischemic or hemorrhagic stroke verified by Computerized Axial Tomography or Magnetic Resonance
- Age above 18 years
- Mini Mental State Examination ≥ 24
- Latency from the event < 3 months
- Presence of clinically significant anxiety and/or depression (Generalized Anxiety Disorder and/or Patient Health Questionnaire ≥10)
Key exclusion criteria (12 listed)
- Clinical instability
- Lesions dated over 3 months from onset
- Multiple or bilateral lesions
- Mini Mental State Examination < 24
- Previous or concomitant neurological, psychiatric, or internal pathologies found in the year preceding the study that, in the judgment of the clinical investigator, may affect the psychological condition and/or interfere with study procedures
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 |
|---|---|---|
| Music interventionAlso: Therapeutic Music ListeningThe intervention will be managed by a professional music therapist with the collaboration of an operator. The music therapist collects data on the clinical history and musical preferences of the patient, which are integrated with the use of specific musical parameters and structures to create personalized playlists lasting 40 minutes. Such playlists aim to reflect the musical tastes of the patient and at the same time to obtain therapeutic objectives inducing relaxation, activation or distraction, depending on the clinical needs. The listening sessions take place daily for one month at a time of day chosen with the patient, who listen to the playlist through the use of a tablet and headphones. The music therapist submits to the patient a brief questionnaire after the first listening and then weekly, to verify the impact of music listening and possibly modify the playlist in line with the patient's feedback and the evolution of the treatment. | Other | Therapeutic Music Listening intervention |
| Control groupStandard treatment is based on daily rehab activities (physical therapy and/or occupational therapy) and weekly psychological support sessions. | Other | Control group |
Primary outcome
Effectiveness of Therapeutic Music Listening (TML) on anxiety in post stroke patients
Time frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of anxiety, that will be measured using the Generalized Anxiety Disorder scale (GAD-7). In this scale scores range from 0 to 21 with higher scores indicating more severe GAD symptoms.
Effectiveness of Therapeutic Music Listening (TML) on depression in post stroke patients
Time frame: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of depression, that will be measured using the Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 with higher scores indicating more severe PHQ symptoms.
Effectiveness of Therapeutic Music Listening (TML) on quality of life in post stroke patients
Time frame: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of quality of life, that will be measured using the EuroQol-5D (EQ-5D). Scores are of two types: the Utility Index (EQ-5D Index), that represents the ratio between health state and social utility, and the Visual Analogue Scale (EQ-VAS) that represents the subjective self-perception of health. The EQ-5D Index ranges from 0.000 to 1.000 with the latter indicating "full health" and the EQ-VAS ranges from 0 to 100 with the latter indicating the best state of health.
Effectiveness of Therapeutic Music Listening (TML) on cognitive outcomes in post stroke patients
Time frame: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of cognitive outocomes (with particular focus on Memory and Attention), that will be measured using the Monteral Cognitive Assessment (MoCA). Scores range from 0 to 30 with scores of 26 or above considered normal.
2 secondary outcomes
fMRI investigation on the resting-state brain activity modifications
Time frame: From enrollment to end of treatment at 4 weeks.
fMRI investigation on the brain macrostructure modifications
Time frame: From enrollment to end of treatment at 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 25 Feb 2026.
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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 Music intervention in people with Post Stroke and Anxiety, 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 6 inclusion and 12 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 25 Feb 2026. 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 Alfredo Raglio (+39 3387291944, alfredo.raglio@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Therapeutic Music Listening (TML) on anxiety in post stroke patients (time frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.