Alterations in the Brain's Connectome After Severe Traumatic Brain Injury
NCT02424656 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35
Last updated 2023-09-13
Summary
This study explores the changes in whole-brain connectivity that occur during recovery from severe Traumatic Brain Injury and how these changes are related to the recovery of consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the TBI episode.
Conditions
- Traumatic Brain Injury
- Disorders of Consciousness
Interventions
- PROCEDURE
-
MRI
EEG-functional MRI, structural MRI, diffusion MRI
- PROCEDURE
-
TMS-EEG
Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
- PROCEDURE
-
FDG-PET
- OTHER
-
Clinical scales
Evaluation of DOC: Coma recovery scale-Revised (CRS-R) and Rancho Los Amigos Scale (RLAS). Evaluation of function: Functional Independent Measure (FIMTM), and Early Functional Assessment (EFA).
Sponsors & Collaborators
-
University of Milan
collaborator OTHER -
University of Kiel
collaborator OTHER -
Glostrup University Hospital, Copenhagen
collaborator OTHER -
Lundbeck Foundation
collaborator OTHER -
Danish Council for Independent Research
collaborator OTHER -
Region Capital Denmark
collaborator OTHER -
Danish Research Centre for Magnetic Resonance
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2021-09-30
- Completion
- 2021-09-30
Countries
- Denmark
Study Locations
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