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StrokeIMLNCT07127159

Music Listening for Mental Health Recovery After Stroke

A study testing Intentional Music Listening and Audiobook Listening in people with Stroke, run by New York University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to explore whether listening to music intentionally can support the mental health of people recovering from a stroke. The question the investigators aim to answer is: Can intentional music listening improve emotional well-being in stroke survivors? And if so, what kinds of changes might music listening… Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Stroke
What is being tested?
Intentional Music Listening and Audiobook Listening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Jul 2025to 30 Sep 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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants aged 50 to 90
  • Confirmed diagnosis of ischemic or hemorrhagic stroke occurring at least six months prior to enrollment.

Who cannot join

  • Significant hearing loss, defined by a score >26 on the Hearing Handicap Inventory for the Elderly Screening (HHIE-S; Ventry and Weinstein, 1982)
  • Contraindications for MRI
  • Significant cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) score below 22 (unless the lower score is attributable to expressive aphasia)
  • Specific musical anhedonia, defined as a score below 60 on the Barcelona Music Reward Questionnaire (BMRQ; Mas-Herrero et al., 2013)
  • Amusia, defined as a score below 70% on the Montreal Battery of Evaluation of Amusia (MBEA; Peretz et al., 2003).
  • Participants will not be excluded if currently taking medications that may affect brain function (e.g., antidepressants) or if engaged in other complementary therapies (e.g., mindfulness, yoga). Participants will be allowed to initiate new medications or therapies during the study period.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pablo Ripolles, PhD contact

+ 1212-998-5424

pripolles@nyu.edu

United States1 site, 1 recruiting
  • New York University

    New York, New York, 10003

    Pablo Ripolles, PhD, 212-998-5424, pr82@nyu.edu

    Pablo Ripolles, PhD

    Recruiting

Other trials in United States

About this study

Official title: Feasibility of a Music Listening Intervention for Mental Health Recovery in Chronic Stroke

This study aims to explore whether listening to music intentionally can support the mental health of people recovering from a stroke. The question the investigators aim to answer is: Can intentional music listening improve emotional well-being in stroke survivors? And if so, what kinds of changes might music listening induce in mental health, thinking and memory (cognition), and brain activity? Participants will be randomly assigned to listen to either music or an audiobook for one hour each day, at home, for four weeks. Participants will also attend four in-person sessions with the researchers: at the start of the study (baseline), just before the listening period begins, after the four weeks are complete, and at a follow-up. During these visits, researchers will gather information about participants' mood and mental health (via questionnaires), assess memory and attention (via cognitive tasks), and use MRI scans to look at brain activity.

Read the detailed description

This is a feasibility clinical trial of a remotely delivered music listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural, and physiological changes.

Specifically, this is a parallel-group randomized controlled feasibility trial enrolling patients with chronic stroke. Participants will be randomized to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week pre-intervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (i.e., track identity, duration, and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioral outcomes related to mental health will be assessed at baseline, pre-intervention, post-intervention, and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity, and heart rate) will be collected pre- and post-intervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, fidelity, feasibility, acceptability, and burden. Secondary outcomes include recruitment and randomization rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for post-stroke mental health recovery.

Conditions
Stroke
Being tested
Intentional Music Listening, Audiobook Listening
Keywords
intentional music listening, music intervention, stroke, mental health, stroke recovery, music therapy, emotional well-being
Medical subject headings
Stroke, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intentional Music ListeningBehavioural

    Participants will receive an iPad with Spotify (for music listening) and FaceTime. For 4 weeks (excluding weekends; 20 sessions), participants will listen to music for one hour per session, without multitasking (e.g., no chores or cooking), and will be encouraged to listen attentively. The investigators will collaborate with each participant to co-create a personalized playlist composed of self-selected, culturally relevant songs. This playlist can be updated at any time by the participant, either independently or with assistance from the team. During the music-listening session, participants will be on FaceTime with a team member, who will be available to provide support as needed. A custom Python script will continuously track the songs played by participants through Spotify, logging playback activity for research purposes.

  • Audiobook ListeningBehavioural

    Participants will be provided with an iPad equipped with a Spotify (for audiobook listening) and FaceTime. For 4 weeks (excluding weekends; 20 sessions), participants will be asked to listen to an audiobook of their choice for one hour per session, without engaging in other activities such as chores or cooking. Participants will be instructed to listen attentively and avoid multitasking during the session. A team member will connect with each participant via FaceTime to offer support. Participants may update or change their audiobook selections at any time, either independently or with help from the team. A custom Python script will be used to continuously track audiobook playback activity for research and analysis.

Study groups in NCT07127159
Study groupRoleWhat they receive
Intentional Music ListeningExperimentalStroke patients assigned to the Intentional Music Listening group will participate in a 4-week intervention, in which participants will engage in one hour of music listening per day and complete daily self-reports on mood and control measures. Baseline, pre-, and post-intervention evaluations will assess clinical outcomes through behavioral measures of mental health and cognition. Pre- and post-intervention evaluations will also include biomarker assessments (MRI and physiological measures). The follow-up session will assess clinical outcomes only.
Receives: Behavioral: Intentional Music Listening
Audiobook ListeningActive comparatorStroke patients assigned to the Audiobook Listening group will participate in a 4-week intervention, in which participants will engage in one hour of audiobook listening per day and complete daily self-reports on mood and control measures. Baseline, pre-, and post-intervention evaluations will assess clinical outcomes through behavioral measures of mental health and cognition. Pre- and post-intervention evaluations will also include biomarker assessments (MRI and physiological measures). The follow-up session will assess clinical outcomes only.
Receives: Behavioral: Audiobook Listening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burden (Completion of evaluation sessions)

    Burden associated with each of the four evaluation sessions will be assessed. The outcome measure will include the proportion of patients who complete evaluations at each time point, with a target of at least 80% completion.

    Measured: From baseline to follow-up (3 months post-intervention)

  2. Burden Ratings

    Investigators will assess the perceived burden of participants by collecting at each evaluation session burden ratings. Participants will rate sessions as "not burdensome," "partially burdensome," or "very burdensome". The goal is for at least 80% of patients to rate the evaluations at each time point as "not burdensome. Burden ratings will be collected at 4 time points (baseline, pre-intervention, post-intervention and follow-up).

    Measured: From baseline to follow-up (3 months post-intervention)

  3. Patient acceptability

    After each listening session, participants will rate the session as "not acceptable," "partially acceptable," or "fully acceptable." The goal is for at least 80% of sessions to be rated as fully acceptable.

    Measured: From beginning to end of the intervention (4 weeks)

  4. Retention and Adherence

    Proportion of enrolled and randomized participants who complete the IML/Audiobook sessions. At least 80% of randomized patients complete at least 80% of the IML/Audiobook sessions.

    Measured: From beginning to end of the intervention (4 weeks)

  5. Feasibility Ratings

    Each listening session will be rated by the study team member leading the session as "not feasible," "partially feasible," or "fully feasible." The primary feasibility outcome measure is the proportion of sessions rated "fully feasible," with a target threshold of 80%.

    Measured: From beginning to the end of the intervention (4 weeks)

  6. Fidelity

    Fidelity will be measured as the the proportion of listening sessions delivered according to the protocol; video calls with patients will be recorded and a team member who was not present during the call will review the recordings and score the session as "delivered according to protocol" or "not delivered according to protocol". Benchmark for success: At least 80% of all sessions delivered according to the protocol.

    Measured: From beginning to the end of the intervention (4 weeks)

Secondary outcomes (3)
  1. Recruitment

    Recruitment will be measured by the number of participants successfully enrolled per month. The target benchmark is a minimum of 2 participants enrolled each month.

    Measured: Baseline

  2. Randomization (Enrolment)

    Randomization will be evaluated based on the proportion of screened participants who are successfully enrolled. The target benchmarks is for at least 30% of screened participants to be enrolled.

    Measured: Baseline

  3. Randomization (Participation)

    Randomization will be evaluated based on the proportion of enrolled participants who complete both the baseline and pre-intervention evaluations and attend at least one IML or Audiobook session. The target benchmark is for at least 80% of enrolled participants to reach this initial level of study engagement.

    Measured: Baseline, pre-intervention, and intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start1 Jul 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07127159
Sponsor's protocol ID
FY2024-8826
Acronym
IML
Status last verified
Aug 2025
First submitted
4 Aug 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Experimental data, devoid of any personal information, will be released as an open-source database.

Publications

  • Sihvonen AJ, Leo V, Ripolles P, Lehtovaara T, Ylonen A, Rajanaro P, Laitinen S, Forsblom A, Saunavaara J, Autti T, Laine M, Rodriguez-Fornells A, Tervaniemi M, Soinila S, Sarkamo T. Vocal music enhances memory and language recovery after stroke: pooled results from two RCTs. Ann Clin Transl Neurol. 2020 Nov;7(11):2272-2287. doi: 10.1002/acn3.51217. Epub 2020 Oct 6.

    PubMed 33022148
  • Baylan S, Haig C, MacDonald M, Stiles C, Easto J, Thomson M, Cullen B, Quinn TJ, Stott D, Mercer SW, Broomfield NM, Murray H, Evans JJ. Measuring the effects of listening for leisure on outcome after stroke (MELLO): A pilot randomized controlled trial of mindful music listening. Int J Stroke. 2020 Feb;15(2):149-158. doi: 10.1177/1747493019841250. Epub 2019 Apr 2.

    PubMed 30940047
  • Sarkamo T, Tervaniemi M, Laitinen S, Forsblom A, Soinila S, Mikkonen M, Autti T, Silvennoinen HM, Erkkila J, Laine M, Peretz I, Hietanen M. Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain. 2008 Mar;131(Pt 3):866-76. doi: 10.1093/brain/awn013.

    PubMed 18287122
  • Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.

    PubMed 28663005
  • Provias V, Kucukoglu MA, Robinson A, Yandun-Oyola S, He R, Palumbo A, Sihvonen AJ, Shi Y, Malgaroli M, Schambra H, Fuentes M, Ripolles P. Remote intentional music listening intervention to support mental health in individuals with chronic stroke: study protocol for a feasibility trial. BMJ Open. 2025 Sep 18;15(9):e109467. doi: 10.1136/bmjopen-2025-109467.

    PubMed 40973376
  • Provias V, Kucukoglu MA, Robinson A, Yandun-Oyola S, He R, Palumbo A, Sihvonen AJ, Shi Y, Malgaroli M, Schambra H, Fuentes M, Ripolles P. Feasibility Trial Protocol for a Remote Intentional Music Listening Intervention to Support Mental Health in Individuals with Chronic Stroke. medRxiv [Preprint]. 2025 Aug 19:2025.08.15.25333806. doi: 10.1101/2025.08.15.25333806.

    PubMed 40894150

Questions about this trial

What is this clinical trial studying?

A study testing Intentional Music Listening and Audiobook Listening in people with Stroke, run by New York University at 1 site in United States.

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 2 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 12 Aug 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 United States. 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 Pablo Ripolles, PhD (+ 1212-998-5424, pripolles@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burden (Completion of evaluation sessions) (time frame: From baseline to follow-up (3 months post-intervention)). The study lists 6 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 NCT07127159, which also lists 6 linked publications.

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 12 Aug 2026.

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