Abstract Details

Title A Scoping Review of Registered Clinical Studies on Concussion and Mild Traumatic Brain Injury (2000-2019) Shows an Encouraging Diversity of Research Initiatives, but a Problematic Variability of Injury Definitions.

Topic Neuro Trauma, Critical Care, and Sports Neurology

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-004

Objective To review the definitions and scope of the clinical research on traumatic brain injury (mTBI)/concussion that was registered in the website www.clinicaltrials.gov from 2000 to June/2019.

Background While many patients with concussion or mild mTBI recover completely, prolonged post-concussion symptoms remain a challenge for patients and an opportunity for research. This has led to numerous research initiatives over the last two decades, which were reviewed here.

Design/Methods This scoping review included all clinical studies on diagnosis and management of patients with mTBI/concussion registered in the website from 2000 to June/2019. The terms “concussion, brain” were used for the primary search. Definitions of mTBI/concussion were obtained from the study protocols. When a definition was missing in the website, the study’s principal investigator was contacted for clarification.

Results There were 224 interventional and 95 observational studies. Most of the studies are focused on treatment (54.7%) or diagnosis (37.5%), while 3.4% examined preventive measures, 2.8% evaluated prognostic instruments, and 1.6% developed of registries. Most of the studies were single-center initiatives led by American and Canadian institutions. The definitions of mTBI/concussion differed widely among the studies, and only 109 studies had a definition stated in the protocol or was provided by the investigators after our request.

Conclusions

The results of this review suggest that most of the clinical studies are focused on diagnosis and non-pharmacological therapies for patients with mTBI/concussion. The large number of differing definitions of mTBI/concussion among the studies creates significant limitations when comparing studies regarding diagnostic accuracy, treatment effectiveness, and generalizability. We recommend that the requirements for registering research protocols on concussion/mTBI should include the necessity to state the definition being used and that researchers should agree to use a uniform definition of concussion which excludes all lesions identified by routine structural imaging.

Authors/Disclosures
Julio C. Furlan, MD, PhD, MBA, MSc, F�鶹��ýӳ�� (Lyndhurst Centre, Toronto Rehabilitation Institute; University of Toronto) PRESENTER	The institution of Dr. Furlan has received research support from Wings for Life Spinal Cord Research Foundation. The institution of Dr. Furlan has received research support from Craig H Neilsen Foundation. The institution of Dr. Furlan has received research support from Ontario Neurotrauma Foundation. The institution of Dr. Furlan has received research support from Cervical Spine Research Society. The institution of Dr. Furlan has received research support from J P Bickell Foundation. The institution of Dr. Furlan has received research support from Praxis Spinal Cord Institute. The institution of Dr. Furlan has received research support from Cervical Spine Research Society. The institution of Dr. Furlan has received research support from CRANIA. The institution of Dr. Furlan has received research support from Craig H Neilsen Foundation. The institution of Dr. Furlan has received research support from Cervical Spine Research Society. The institution of Dr. Furlan has received research support from Cervical Spine Research Society. The institution of Dr. Furlan has received research support from Tanenbaum Institute for Science in Sport. .
	No disclosure on file
	No disclosure on file

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