Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:27 AM
Study NCT ID:
NCT07432204
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Music Listening in Post Stroke Patients.
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Study Overview
Official Title:
Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ML4STROKE
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: