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临床试验/NCT03444181
NCT03444181进行中(未招募)不适用

ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients

University of Bergen1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2018年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
136
试验地点
1
主要终点
Brain age

研究概览

简要总结

Music has powerful effects on memory in patients with neurodegenerative diseases. However, although there is anecdotal evidence for beneficial effects of active music interventions in patients with Alzheimer's disease (AD), there is lack of high-quality research investigating this issue, and the cognitive, emotional, and social factors that contribute to potentially beneficial effects of music making in AD patients are largely unknown. In a randomised controlled intervention trial, a cohort of AD patients will undergo twelve months of music lessons specifically tailored for AD patients. Structural and functional magnetic resonance imaging (MRI) will be used to determine changes in brain age (as compared to two control groups), and voxel-based morphometry will be computed to determine contributions of different factors of the music intervention (cognitive, emotional, and social) to plastic changes of brain morphology, and a potential deceleration of brain atrophy. In addition, quality of life of patients. In cooperation with the Bergen municipality, and a strong network of national and international partners, the neurocognitive music therapy will be implemented, involving training of music therapists, and communication of results to patients, patient groups, and therapists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Alzheimer Disease
  • Living independently at home (not in a care home or similar aged care facility)
  • Able to complete questionnaires in Norwegian
  • Able to undergo MRI scans
  • Able to attend interventions and assessments in the area of Bergen, Norway
  • Has given informed consent

排除标准

  • Hearing impairment that cannot be mended by hearing aids
  • Conditions that hinder MRI scans, such as claustrophobia or metal objects in body (e.g. pacemakers)

结局指标

主要结局

Brain age

时间窗: 12 months

MRI-derived estimation of the deviation of a person's brain age from the chronological age of that same person, in months

Depression symptoms

时间窗: 12 months

Sum score of the Geriatric Depression Scale (GDS; 15 yes/no items; possible range of scores 0-15; higher scores indicating more severe depression symptoms)

次要结局

  • Sensori-motor functions(12 months)
  • Cognitive functioning(12 months)
  • Living independently at home(12 months and up to 5 years)
  • Language abilities(12 months)
  • Activities of daily living(12 months)
  • Integrity of fibre tracts(12 months)
  • Resting-state functional connectivity(12 months)
  • Disease progression(12 months)
  • Working alliance(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Koelsch

Professor

University of Bergen

研究点 (1)

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