Traumatic Brain Injury (TBI) Clinical Trial
Official title:
Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury
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.
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.
;
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 |