Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01956136
Study type Interventional
Source Helsinki University
Contact
Status Completed
Phase N/A
Start date March 2014
Completion date December 2018

See also
  Status Clinical Trial Phase
Completed NCT02878577 - Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury
Active, not recruiting NCT02918994 - LearningRx Cognitive Training for TBI N/A
Completed NCT02524067 - Modified Environment for Agitation in Patients With TBI N/A
Completed NCT01760785 - Valproate for Mood Swings and Alcohol Use Following Head Injury N/A
Recruiting NCT05033444 - A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers Phase 1
Not yet recruiting NCT04003285 - Allopregnanolone in Chronic Complex Traumatic Brain Injury Phase 2
Completed NCT01750268 - Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI Phase 4
Recruiting NCT01512524 - Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury N/A
Completed NCT04796207 - The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes N/A
Completed NCT02657135 - Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury N/A
Withdrawn NCT02356861 - LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans N/A
Recruiting NCT04930146 - Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients N/A
Not yet recruiting NCT05675423 - Imaging Characterization of the Biomechanical Coupling of Brain and Skull
Withdrawn NCT01891383 - Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
Completed NCT02764983 - Occupational Therapy Driving Intervention for Returning Combat Veterans. N/A
Withdrawn NCT01779427 - Attention Intervention Management N/A
Completed NCT01118195 - Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans N/A
Completed NCT01547780 - Translocator Protein and Inflammation After Traumatic Brain Injury Phase 1/Phase 2
Recruiting NCT03874208 - Prediction for Coma Recovery With Comaweb N/A
Completed NCT03314584 - Managing MTBI-related Headaches With rTMS N/A