NCT07432204

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Nov 2025Dec 2027

Study Start

First participant enrolled

November 12, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 25, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 30, 2026

Last Update Submit

February 18, 2026

Conditions

Post StrokeAnxietyDepression

Keywords

Therapeutic Music ListeningStrokeAnxietyDepressionNeuroplasticityfMRICognitive functionsConnectivity

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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

    From enrollment to end of treatment at 4 weeks.

  • fMRI investigation on the brain macrostructure modifications

    From enrollment to end of treatment at 4 weeks.

Study Arms (2)

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)

Other: Music intervention

Control group

EXPERIMENTAL

Control group subjected solely to conventional therapeutic interventions.

Other: Control group

Interventions

Music interventionOTHER

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.

Also known as: Therapeutic Music Listening
Therapeutic Music Listening intervention
Control groupOTHER

Standard treatment is based on daily rehab activities (physical therapy and/or occupational therapy) and weekly psychological support sessions.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Salvatore Maugeri I.R.C.C.S.

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepressionStroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Alfredo Raglio

CONTACT

+39 3387291944alfredo.raglio@icsmaugeri.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter randomized controlled single-blind trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 25, 2026

Study Start

November 12, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 25, 2026

Record last verified: 2026-01

Locations

IT(1)