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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2022 |
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Main ID: |
NCT02588482 |
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Date of registration:
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23/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients
COMETIQUE |
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Scientific title:
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Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients |
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Date of first enrolment:
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June 17, 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02588482 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Thierry Moulin, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Service de neurologie, CHRU Besançon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- post anoxic coma
- over 18 years old
- agreement from families
- alive 4 days after the beginning of coma
Exclusion Criteria:
- traumatic coma
- non-traumatic but not anoxic coma
- patients with severe comorbidity previous to coma
- refusal of families to participate to the study
- contraindication to a high-density electroencephalography exam
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Post Anoxic Coma
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Intervention(s)
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Device: high-density electroencephalography
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Device: Conventional electroencephalography
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Primary Outcome(s)
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Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
[Time Frame: 4 days after the beginning of coma]
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Secondary Outcome(s)
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Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
[Time Frame: 19 days after the beginning of coma]
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Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
[Time Frame: 7 days after the beginning of coma]
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Secondary ID(s)
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R/2012/46
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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