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

NCT01956136 | Completed DMC

• 1 other identifier: 141106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Traumatic Brain Injury (TBI)

Outcome Measures

Primary Outcomes (4)

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

  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.

  Baseline, 3 months, 6 months, and 18 months

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

  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.

  Baseline, 3 months, and 6 months

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

  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.

  Baseline, 3 months, and 6 months

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

  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.

  Baseline, 3 months, and 6 months

Secondary Outcomes (5)

• Change in Upper-Extremity Motor Functions during a 6-month follow-up

  Baseline, 3 months, and 6 months

• 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 Structural and Functional Neuroplasticity during a 6-month follow-up

  Baseline, 3 months, and 6 months

Study Arms (2)

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.

Behavioral: Music-based Neurological Rehabilitation (MBNR); Other: Standard Care (SC)

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.

Behavioral: Music-based Neurological Rehabilitation (MBNR); Other: Standard Care (SC)

Interventions

Music-based Neurological Rehabilitation (MBNR) BEHAVIORAL

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.

Arm 1; Arm 2

Standard Care (SC) OTHER

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.

Arm 1; Arm 2

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Helsinki: lead
• Helsinki University Central Hospital: collaborator
• Hospital District of Helsinki and Uusimaa: collaborator
• University of Jyvaskyla: collaborator
• Åbo Akademi University: collaborator
• University of Barcelona: collaborator
• University of Virginia: collaborator
• Validia Rehabilitation Helsinki: collaborator

Study Sites (3)

Helsinki University Central Hospital / Brain Injury Outpatients Clinic

Helsinki, Finland

Location

Validia Rehabilitation Helsinki

Helsinki, Finland

Location

Lohja Hospital, Department of Neurology

Lohja, Finland

Location

Related Publications (1)

• 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.

  PMID: 35456277 DERIVED

Related Links

• Cognitive Brain Research Unit, Helsinki University
• Finnish Centre of Excellence in Interdisciplinary Music Research, University of Jyvaskyla
• Validia Rehabilitation Helsinki
• Cognition and Brain Plasticity Group, University of Barcelona

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Teppo Sarkamo, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Mari Tervaniemi, PhD

  University of Helsinki

  STUDY DIRECTOR

• Anne Vehmas, MD

  Kapyla Rehabilitation Centre, Helsinki, Finland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, PhD

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: October 8, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

FI (3)