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临床试验/NCT01956136
NCT01956136已完成不适用

Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury

University of Helsinki3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
3
主要终点
Change in Verbal and Non-Verbal Reasoning during a 6-month follow-up

研究概览

简要总结

Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life and ability to work. The purpose of the study is to determine the long-term effect of music-based rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.

详细描述

Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life (QoL) and ability to work dramatically, thereby bringing about a lot of suffering and burden to the patients and their families as well as substantial social and economic costs to the society. Early rehabilitation is highly important for restoring lost skills and functioning, but often very difficult given the severity and extent of the TBI symptoms and the high strain that the available rehabilitation methods put on the patients. Music therapy is a highly motivating, versatile, and applicable form of TBI rehabilitation, but currently there is little scientific evidence for its efficacy or mechanisms in the TBI population. The purpose of the present project is to determine the long-term effect of Music-based Neurological Rehabilitation (MBNR) on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.

The study is a single-blind, cross-over randomized controlled trial (RCT) involving 60 adolescents and young adults with a subacute moderate / severe TBI. During an 18-month follow-up, the patients receive MBNR (30 session, 3 x week, 1 hour sessions) and/or Standard Care (SC). The MBNR intervention utilizes structured cognitive-motor training with drums and creative musical expression (music playing, song writing) with piano that are geared towards engaging and training attention, executive functions, working memory, and upper-extremity functions and for enhancing emotional self-expression, adjustment, and mood after TBI. The SC consists of other types of conventional rehabilitation (e.g., physical therapy, neuropsychological rehabilitation) and medical care for TBI provided in private or public health care. Half of the patients receive the MBNR intervention during the first 10-week period and half during the second 10-week period (in addition, all patients receive SC during the whole follow-up period).

Outcome measures comprise neuropsychological tests (measuring executive functions, attention, reasoning, and working memory and learning), neurological scales (measuring neurological symptoms, functional outcome, adjustment, and participation), motor tests (measuring motor dexterity, coordination, and upper limb functioning), and structural and functional magnetic resonance imaging (MRI/fMRI, measuring gray and white matter structure and integrity and auditory-motor neural processing) performed at the start of the study (baseline), after the first 10-week period (3-month stage) and after the second 10-week period (6-month stage). At these time points as well as 12 months later (18-month stage), the patients and their caregivers are also given questionnaires measuring executive functions, depression symptoms, quality of life, and caregiver well-being and burden.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • moderate-severe TBI that has occurred ≤ 24 months ago
  • cognitive symptoms
  • right-handed
  • living in the Helsinki metropolitan area
  • able to understand the purpose of the study and provide informed consent

排除标准

  • prior neurological or psychiatric illness or substance abuse
  • prior auditory deficits (severe hearing loss, tinnitus, etc.)
  • contraindications for MRI (pacemaker, metal prosthesis, etc.)

研究组 & 干预措施

Arm 1

Experimental

The patients receive 10 weeks of Music-based Neurological Rehabilitation (MBNR) and Standard Care (SC) followed by 10 weeks of SC only.

干预措施: Music-based Neurological Rehabilitation (MBNR) (Behavioral)

Arm 1

Experimental

The patients receive 10 weeks of Music-based Neurological Rehabilitation (MBNR) and Standard Care (SC) followed by 10 weeks of SC only.

干预措施: Standard Care (SC) (Other)

Arm 2

Experimental

The patients receive 10 weeks of Standard Care (SC) only followed by 10 weeks of Music-based Neurological Rehabilitation (MBNR) and SC.

干预措施: Music-based Neurological Rehabilitation (MBNR) (Behavioral)

Arm 2

Experimental

The patients receive 10 weeks of Standard Care (SC) only followed by 10 weeks of Music-based Neurological Rehabilitation (MBNR) and SC.

干预措施: Standard Care (SC) (Other)

结局指标

主要结局

Change in Verbal and Non-Verbal Reasoning during a 6-month follow-up

时间窗: Baseline, 3 months, and 6 months

Verbal and Non-Verbal Reasoning are assessed using the Similarities and Block Design subtests of the Wechsler Adult Intelligence Scale IV (WAIS-IV) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.

Change in Verbal Working Memory and Learning during a 6-month follow-up

时间窗: Baseline, 3 months, and 6 months

Verbal Working Memory and Learning are assessed using the Digit Span subtest of the Wechsler Adult Intelligence Scale IV (WAIS-IV) and the Word List I \& II subtests of the Wechsler Memory Scale III (WMS-III) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.

Change in Executive Functions during an 18-month follow-up

时间窗: Baseline, 3 months, 6 months, and 18 months

Executive Functions (EF) are assessed using the Behavior Rating Inventory of Executive Functions (BRIEF-A, both self-report and informant-report versions) questionnaire and following cognitive tests: Frontal Assessment Battery (FAB, measure of overall EF), Number-Letter Task (measure of set-shifting ability), Simon Task (measure of inhibition), and Auditory N-back Task (measure of working memory updating). The cognitive tests are performed at the baseline, 3-month, and 6-month stages and the BRIEF-A is performed at the baseline, 3-month, 6-month, and 18-month stages. Changes from baseline to each follow-up point (3-month / 6-month / 18-month) and between the follow-up points are evaluated.

Change in Focused and Sustained Attention during a 6-month follow-up

时间窗: Baseline, 3 months, and 6 months

Focused and Sustained Attention is assessed using the Sustained Attention to Response Task (SART) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are evaluated.

次要结局

  • Change in Depression during an 18-month follow-up(Baseline, 3 months, 6 months, and 18 months)
  • Change in Quality of Life during an 18-month follow-up(Baseline, 3 months, 6 months, and 18 months)
  • Change in Emotional Well-being of Family Members during an 18-month follow-up(Baseline, 3 months, 6 months, and 18 months)
  • Change in Upper-Extremity Motor Functions during a 6-month follow-up(Baseline, 3 months, and 6 months)
  • Change in Structural and Functional Neuroplasticity during a 6-month follow-up(Baseline, 3 months, and 6 months)

研究者

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

Teppo Sarkamo

Researcher, PhD

University of Helsinki

研究点 (3)

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