Clinical trial NCT01956136: Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury
Official title: Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury (TBI)
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Hospital District of Helsinki and Uusimaa
name: University of Jyvaskyla
name: Åbo Akademi University
name: University of Barcelona
name: University of Virginia
name: Validia Rehabilitation Helsinki
First posted: 2013-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Executive Functions during an 18-month follow-up
timeFrame: Baseline, 3 months, 6 months, and 18 months
measure: Change in Focused and Sustained Attention during a 6-month follow-up
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Verbal Working Memory and Learning during a 6-month follow-up
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Verbal and Non-Verbal Reasoning during a 6-month follow-up
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Change in Upper-Extremity Motor Functions during a 6-month follow-up
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Depression during an 18-month follow-up
timeFrame: Baseline, 3 months, 6 months, and 18 months
measure: Change in Quality of Life during an 18-month follow-up
timeFrame: Baseline, 3 months, 6 months, and 18 months
measure: Change in Emotional Well-being of Family Members during an 18-month follow-up
timeFrame: Baseline, 3 months, 6 months, and 18 months
measure: Change in Structural and Functional Neuroplasticity during a 6-month follow-up
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital / Brain Injury Outpatients Clinic
city: Helsinki
country: Finland
facility: Validia Rehabilitation Helsinki
city: Lohja
country: Finland
facility: Lohja Hospital, Department of Neurology
Study officials:
affiliation: University of Helsinki
name: Teppo Sarkamo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki
name: Mari Tervaniemi, PhD
role: STUDY_DIRECTOR
affiliation: Kapyla Rehabilitation Centre, Helsinki, Finland
name: Anne Vehmas, MD
role: STUDY_CHAIR
References:
citation: Sihvonen AJ, Siponkoski ST, Martinez-Molina N, Laitinen S, Holma M, Ahlfors M, Kuusela L, Pekkola J, Koskinen S, Sarkamo T. Neurological Music Therapy Rebuilds Structural Connectome after Traumatic Brain Injury: Secondary Analysis from a Randomized Controlled Trial. J Clin Med. 2022 Apr 14;11(8):2184. doi: 10.3390/jcm11082184.