Recruiting

EEG

Sponsor:

Genevieve Du Pont-Thibodeau

Code:

NCT03343964

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Amplitude-integrated electroencephalography

Study Details

Brief summary:

The goal of this study is to determine whether the addition of aEEG to cEEG in clinical practice does in fact help PICU physicians detect subclinical seizures in this population.

Conditions

Traumatic Brain Injury

Study ID

NCT03343964

Start date

Feb 5, 2018

Status verified date

Feb, 2018

Completion date

Feb, 2020

Anticipated

Primary completion date

Feb, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • moderate to severe TBI defined by a post-resuscitation Glasgow Coma Scale (GCS) of 3-8 (severe) or 9-12 (moderate), this includes those with accidental TBI, abusive head trauma, and cases of polytrauma
  • decision by the primary medical team to initiate cEEG monitoring

Exclusion Criteria:

  • patients for whom it is impossible to record cEEG for any reason will be excluded from the study
  • premature neonates
  • brain death or suspected brain death at PICU entry
  • unavailable equipment for cEGG and/or aEEG
  • consent to participate denied by parents and/or patient

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with moderate to severe TBI

Interventions

Amplitude-integrated electroencephalography

Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.

Primary outcome measure

  • accuracy of PICU physicians at detecting seizures when using aEEG in real-life clinical setting during the continuous EEG monitoring of patients with moderate to severe TBI [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Ilona Shemyakina, BSc

514-345-4931ilona.shemyakina@recherche-ste-justine.qc.ca

Lucy Clayton, MSc

514-345-4931lucy.clayton@recherche-ste-justine.qc.ca

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Ilona Shemyakina, BSc

15143454931ilona.shemyakina@recherche-ste-justine.qc.ca

Principal Investigator:

Geneviève Du Pont-Thibodeau, MD

More Information

Sponsor

Genevieve Du Pont-Thibodeau

Last update posted

Mar 1, 2018

Last verified

Feb, 2018

Keywords

  • aEEG, cEEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genevieve Du Pont-Thibodeau on 2018-03-01.