Traumatic Brain Injury (TBI) Clinical Trial
— MUBIOfficial title:
Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury
NCT number | NCT01956136 |
Other study ID # | 141106 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | December 2018 |
Verified date | February 2019 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 60 Years |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Central Hospital / Brain Injury Outpatients Clinic | Helsinki | |
Finland | Validia Rehabilitation Helsinki | Helsinki | |
Finland | Lohja Hospital, Department of Neurology | Lohja |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Åbo Akademi University, Helsinki University Central Hospital, Hospital District of Helsinki and Uusimaa, University of Barcelona, University of Jyvaskyla, University of Virginia, Validia Rehabilitation Helsinki |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change in Upper-Extremity Motor Functions during a 6-month follow-up | 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. | Baseline, 3 months, and 6 months | |
Secondary | Change in Depression during an 18-month follow-up | 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. | Baseline, 3 months, 6 months, and 18 months | |
Secondary | Change in Quality of Life during an 18-month follow-up | 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. | Baseline, 3 months, 6 months, and 18 months | |
Secondary | Change in Emotional Well-being of Family Members during an 18-month follow-up | 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. | Baseline, 3 months, 6 months, and 18 months | |
Secondary | Change in Structural and Functional Neuroplasticity during a 6-month follow-up | 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. | Baseline, 3 months, and 6 months |
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