Clinical Trials Logo
  1. Home
  2. Traumatic Brain Injury
  3. NCT04712591
  4. Details
NCT04712591 Clinical Trial

The EBC Recovery Study

Traumatic Brain Injury Clinical Trial

Official title:
Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04712591
Other study ID # 20191143
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 18, 2020
Est. completion date January 1, 2026

Study information
Verified date November 2023
Source University of Miami
Contact Ayham Alkhachroum, MD
Phone (305) 243-3218
Email axa2610@med.miami.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research study to find out if clinically unconscious acute traumatic brain injury patients that show brain activation on electroencephalogram (EEG) (bedside test) have better results and wake up in the future.

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date January 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: For TBI Participants - TBI adult (18 years and older) patients who are admitted to the intensive care unit - Unconscious with Glasgow Coma Scale (GCS) <8 on presentation and unable to follow bedside commands. - A negative COVID-19 test on arrival For Healthy Volunteers: - 18 years and older Exclusion Criteria: For All Participants: - <18 years of age - Pregnant woman - Patients with cardiac arrest on presentation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Jackson Memorial Hospital Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glasgow Outcome Scale-Extended (GOSE) Scale The GOSE is an outcome scale, range 1-8 evaluating the patients' functional outcomes - higher score indicates better recovery Up to 5 years
Secondary Coma Recovery Scale - Revised (CRS-R) The CRS-R will evaluate the patients' conscious state, range 0-23 -higher score indicates a better conscious state Up to 5 years
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Terminated NCT03698747 - Myelin Imaging in Concussed High School Football Players
Recruiting NCT05130658 - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training N/A
Recruiting NCT04560946 - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI N/A
Completed NCT05160194 - Gaining Real-Life Skills Over the Web N/A
Recruiting NCT02059941 - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04465019 - Exoskeleton Rehabilitation on TBI
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Suspended NCT04244058 - Changes in Glutamatergic Neurotransmission of Severe TBI Patients Early Phase 1
Completed NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Recruiting NCT04274777 - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Withdrawn NCT04199130 - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI N/A
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1