Post Anoxic ComaCOMETIQUENCT02588482
Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients
A study testing high-density electroencephalography and Conventional electroencephalography in people with Post Anoxic Coma, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Anoxic Coma
- What is being tested?
- high-density electroencephalography and Conventional electroencephalography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2013to 8 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post anoxic coma
- over 18 years old
- agreement from families
- alive 4 days after the beginning of coma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients
The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients
- Conditions
- Post Anoxic Coma
- Being tested
- high-density electroencephalography, Conventional electroencephalography
- Keywords
- electroencephalography (EEG), mismatch negativity (MMN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-density electroencephalographyDevice
Auditory stimulations during electroencephalography recording
Conventional electroencephalographyDevice
Auditory stimulations during electroencephalography recording
| Study group | Role | What they receive |
|---|---|---|
| electroencephalography recording | Experimental | Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously Receives: Device: high-density electroencephalography; Device: Conventional electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
mismatch negativity is an electrophysiological response recorded after the presentation of deviant auditory stimulations Recovery is assessed 1 month after the beginning of coma
Measured: 4 days after the beginning of coma
Secondary outcomes (2)
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Measured: 7 days after the beginning of coma
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Measured: 19 days after the beginning of coma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start17 Jun 2013
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Why it stopped: Recruitment and feasability issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Anoxic ComaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Moulin, MD, PhD, Principal investigator, Service de neurologie, CHRU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588482
- Sponsor's protocol ID
- R/2012/46
- Acronym
- COMETIQUE
- Status last verified
- Nov 2022
- First submitted
- 23 Oct 2015
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients
- ClinicalTrials.gov ID
- NCT02588482
- Acronym / sponsor ID
- COMETIQUE / R/2012/46
- Conditions
- Post Anoxic Coma
- Keywords
- electroencephalography (EEG), mismatch negativity (MMN)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and feasability issues
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 17 Jun 2013 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electroencephalography recording | Experimental | Device: high-density electroencephalography, Device: Conventional electroencephalographyCerebral measurements from high-density and conventional electroencephalography are recorded simultaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- post anoxic coma
- over 18 years old
- agreement from families
- alive 4 days after the beginning of coma
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-density electroencephalographyAuditory stimulations during electroencephalography recording | Device | electroencephalography recording |
| Conventional electroencephalographyAuditory stimulations during electroencephalography recording | Device | electroencephalography recording |
Primary outcome
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
mismatch negativity is an electrophysiological response recorded after the presentation of deviant auditory stimulations Recovery is assessed 1 month after the beginning of coma
2 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Recruitment and feasability issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Related trials for Post Anoxic Coma
RecruitingObservational study
Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
Cardiac Arrest (CA), Anoxic Brain Injury
Not yet recruitingObservational study
QUality Of Life and surviVAl in carDIac arreSt Patients
Cardiac Arrest, Post-Anoxic Coma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Moulin, MD, PhD principal investigator
Service de neurologie, CHRU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-density electroencephalography and Conventional electroencephalography in people with Post Anoxic Coma, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment and feasability issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.