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治験 NCT07127159 (IML)（対象：脳卒中）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ニューヨーク大学Music Listening for Mental Health Recovery After Stroke (IML) 60 自宅
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07127159 (IML) は 介入研究 臨床試験 で、脳卒中 に関するものです。現在は 募集中 で、2025年7月1日 から開始しています。60 名の参加者 の募集が計画されています。この試験は ニューヨーク大学 によって主導され、2026年9月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月25日 です。
概要
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 r...もっと見る
詳細説明
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...
もっと見る公式タイトル
Feasibility of a Music Listening Intervention for Mental Health Recovery in Chronic Stroke
疾患名
脳卒中刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- IML
- FY2024-8826
NCT番号
開始日
2025-07-01
最終更新日
2025-09-25
終了予定日
2026-09-30
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
intentional music listening
music intervention
stroke
mental health
stroke recovery
music therapy
emotional well-being
music intervention
stroke
mental health
stroke recovery
music therapy
emotional well-being
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Intentional Music Listening Stroke 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 evaluatio...もっと見る | Intentional Music Listening 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 r...もっと見る |
実薬対照薬Audiobook Listening Stroke 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 w...もっと見る | Audiobook Listening 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 mem...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. | From baseline to follow-up (3 months post-intervention) |
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). | From baseline to follow-up (3 months post-intervention) |
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. | From beginning to end of the intervention (4 weeks) |
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. | From beginning to end of the intervention (4 weeks) |
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%. | From beginning to the end of the intervention (4 weeks) |
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. | From beginning to the end of the intervention (4 weeks) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. | Baseline |
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. | Baseline |
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. | Baseline, pre-intervention, and intervention |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
50 Years
対象性別
全て
- Participants aged 50 to 90
- Confirmed diagnosis of ischemic or hemorrhagic stroke occurring at least six months prior to enrollment.
- 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.
ニューヨーク大学試験中央連絡先
連絡先: Pablo Ripolles, PhD, + 1212-998-5424, [email protected]
1 1カ国の場所
New York
New York University, New York, New York, 10003, United States
Pablo Ripolles, PhD, 連絡先, 212-998-5424, [email protected]
Pablo Ripolles, PhD, 主任研究者
募集中