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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Helsinki University
Sponsor:
Collaborators:
Kapyla Rehabilitation Centre, Finland
Helsinki University Central Hospital
HUS Helsinki Medical Imaging Center, Finland
University of Jyvaskyla
Åbo Akademi University
University of Barcelona
University of Virginia
Information provided by (Responsible Party):
Teppo Sarkamo, Helsinki University
ClinicalTrials.gov Identifier:
NCT01956136
First received: September 12, 2013
Last updated: October 1, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Traumatic Brain Injury (TBI)
Behavioral: Music-based Neurological Rehabilitation (MBNR)
Other: Standard Care (SC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Change in Executive Functions during an 18-month follow-up [ Time Frame: Baseline, 3 months, 6 months, and 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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.

  • Change in Verbal Working Memory and Learning during a 6-month follow-up [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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 Verbal and Non-Verbal Reasoning during a 6-month follow-up [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Upper-Extremity Motor Functions during a 6-month follow-up [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Upper-Extremity Motor Functions are assessed using the Purdue Pegboard Test (PPT, measure of fine and gross motor dexterity and coordination), the Action Research Arm Test (ARAT, measure of fine and gross upper limb functioning), and the Box and Block Test (BBT, measure of unilateral manual dexterity) performed at the baseline, 3-month, and 6-month stages. Changes from baseline to each follow-up point (3-month / 6-month) and between follow-up points are evaluated.

  • Change in Depression during an 18-month follow-up [ Time Frame: Baseline, 3 months, 6 months, and 18 months ] [ Designated as safety issue: No ]
    Depression is assessed using the Beck Depression Inventory II (BDI-II, self-report version) questionnaire 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 Quality of Life during an 18-month follow-up [ Time Frame: Baseline, 3 months, 6 months, and 18 months ] [ Designated as safety issue: No ]
    Quality of Life is assessed using the Quality of Life after Brain Injury (QOLIBRI, both self-report and informant-report versions) questionnaire 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 Emotional Well-being of Family Members during an 18-month follow-up [ Time Frame: Baseline, 3 months, 6 months, and 18 months ] [ Designated as safety issue: No ]
    Emotional Well-being of Family Members is assessed using the General Health Questionnaire (GHQ) and the Modified Caregiver Appraisal Scale (MPAI) given to the family member of the patient 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 Structural and Functional Neuroplasticity during a 6-month follow-up [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Structural and Functional Neuroplasticity is measured using structural and functional magnetic resonance imaging (MRI/fMRI) scanning performed at the baseline, 3-month, and 6-month stages. Overall, the purpose of the MRI/fMRI is to determine the exact location and size of the lesions and other pathological changes caused by the TBI and to study the changes in grey matter volume (using voxel-based morphometry, VBM), white matter volume and organization (using diffusion tensor imaging, DTI), and auditory-motor activity and connectivity (using fMRI) that take place in different brain areas during the 6-month follow-up and to correlate these changes to behavioral recovery. Changes from baseline to each follow-up point (3-month / 6-month) and between the follow-up points are studied.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
The patients receive 10 weeks of Music-based Neurological Rehabilitation (MBNR) and Standard Care (SC) followed by 10 weeks of SC only.
Behavioral: Music-based Neurological Rehabilitation (MBNR)
Music-based Neurological Rehabilitation (MBNR) will involve 10 weeks of individual training (30 sessions, 1 hour per session, 3 days per week) given by a trained music therapist. The MBNR protocol utilizes structured cognitive-motor training with drums (drum set, djembe 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.
Other: Standard Care (SC)
Standard Care (SC) consists of other types of conventional rehabilitation (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation) and medical care for TBI that the patients receive in Finnish private or public health care.
Experimental: Arm 2
The patients receive 10 weeks of Standard Care (SC) only followed by 10 weeks of Music-based Neurological Rehabilitation (MBNR) and SC.
Behavioral: Music-based Neurological Rehabilitation (MBNR)
Music-based Neurological Rehabilitation (MBNR) will involve 10 weeks of individual training (30 sessions, 1 hour per session, 3 days per week) given by a trained music therapist. The MBNR protocol utilizes structured cognitive-motor training with drums (drum set, djembe 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.
Other: Standard Care (SC)
Standard Care (SC) consists of other types of conventional rehabilitation (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation) and medical care for TBI that the patients receive in Finnish private or public health care.

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

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate-severe TBI that has occurred ≤ 6 months ago
  • prefrontal damage and 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956136

Contacts
Contact: Anne Vehmas, MD (358) 447650657 anne.vehmas@invalidiliitto.fi

Locations
Finland
Kapyla Rehabilitation Centre Not yet recruiting
Helsinki, Finland
Contact: Anne Vehmas, MD    (358) 447650657    anne.vehmas@invalidiliitto.fi   
Helsinki University Central Hospital / Brain Injury Outpatients Clinic Not yet recruiting
Helsinki, Finland
Contact: Aarne Ylinen, MD, PhD    (358) 9 47174545    aarne.ylinen@hus.fi   
Sponsors and Collaborators
Helsinki University
Kapyla Rehabilitation Centre, Finland
Helsinki University Central Hospital
HUS Helsinki Medical Imaging Center, Finland
University of Jyvaskyla
Åbo Akademi University
University of Barcelona
University of Virginia
Investigators
Principal Investigator: Teppo Sarkamo, PhD Helsinki University
Study Director: Mari Tervaniemi, PhD Helsinki University
Study Chair: Anne Vehmas, MD Kapyla Rehabilitation Centre, Helsinki, Finland
  More Information

Additional Information:
No publications provided

Responsible Party: Teppo Sarkamo, Researcher, PhD, Helsinki University
ClinicalTrials.gov Identifier: NCT01956136     History of Changes
Other Study ID Numbers: 141106
Study First Received: September 12, 2013
Last Updated: October 1, 2013
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 19, 2014