ComaACI-ComaNCT01620957
Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma
An observational study of Coma, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coma
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2012to Jul 2017
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will analyse DMN functional and anatomical connectivity in severely brain-injured patients in coma and during the first two month following brain injury. All patients will be admitted from one of the four Critical Care Units of University Teaching Hospital of Toulouse, France.
Who may be able to join
- Brain-damaged patients in coma (trauma or anoxic origin).
- Male and female, ranging in age from 18 to 75 years.
Who cannot join
- Withdrawal of consent from the patients (or the persons having legal responsibility for them).
- Sedation or general anaesthesia during assessement period (< 24 hours).
- MRI contraindications
Trial locations and contacts
1 site in 1 country.
France1 site
Institut National de la Santé et de la Recherche Medicale, U825
Toulouse, Haute Garonne, 31059
About this study
Official title: Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience
Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. This interaction permit to make the hypothesis, that baseline brain activity is likely to shape our ongoing " stream of consciousness " and could correlate with conscious perception. The investigators hypothesized that DMN connectivity strength would be related to the level of consciousness of brain-damaged patients. The investigators will follow severely brain-injured patient in coma. Clinical examination using standardized behavioural scales: FOUR score (Full Outline of UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30 (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state between 30 and 60 days, an additional clinical and brain imaging assessment will be performed to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will be performed in patients by a senior anaesthesiologist throughout the experiment.
- Conditions
- Coma
- Keywords
- Default-mode network, Difussion tensor imaging, Cortical thickness, Coma, Vegetative state, Minimally conscious state, Neural correlate of consciousness
- Medical subject headings
- Coma, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coma patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injury
To date, the functional significance of DMN resting state connectivity patterns remain unclear. We hypothesized that DMN connectivity strength would be related to the level of consciousness of non-communicative brain-damaged patients, as assessed by standardized behavioural scales (FOUR score, CRS-R). Furthermore, we expected that a disruption of functional connectivity in the DMN could predict brain-damaged patient's recovery.
Measured: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*)
Secondary outcomes (1)
Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury
Functional DMN connectivity will be investigated using probabilistic independent component analysis. Structural connectivity counterpart, will be assessed by diffusor tensor imaging and cortical thickness.
Measured: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study start10 Jul 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- University Hospital, Toulouse, Association des Traumatisés du Crane et de la Face, Paris, France
- Responsible party
- Sponsor
- Investigators
- Stein Silva, MD, PhD, Principal investigator, Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, FranceKader Boulanouar, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620957
- Sponsor's protocol ID
- C11-55 Inserm
- Other IDs
- 2012-A00009-34
- Acronym
- ACI-Coma
- Status last verified
- Aug 2021
- First submitted
- 11 Apr 2012
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Peran P, Malagurski B, Nemmi F, Sarton B, Vinour H, Ferre F, Bounes F, Rousset D, Mrozeck S, Seguin T, Riu B, Minville V, Geeraerts T, Lotterie JA, Deboissezon X, Albucher JF, Fourcade O, Olivot JM, Naccache L, Silva S. Functional and Structural Integrity of Frontoparietal Connectivity in Traumatic and Anoxic Coma. Crit Care Med. 2020 Aug;48(8):e639-e647. doi: 10.1097/CCM.0000000000004406.
PubMed 32697504Rosazza C, Sattin D, Sebastiano DR, Minati L, Leonardi M, Silva S. Disruption of posteromedial large-scale neural communication predicts recovery from coma. Neurology. 2016 Jul 5;87(1):120-1. doi: 10.1212/WNL.0000000000002853. No abstract available.
PubMed 27378806
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience
- ClinicalTrials.gov ID
- NCT01620957
- Acronym / sponsor ID
- ACI-Coma / C11-55 Inserm
- Conditions
- Coma
- Keywords
- Default-mode network, Difussion tensor imaging, Cortical thickness, Coma, Vegetative state, Minimally conscious state, Neural correlate of consciousness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- University Hospital, Toulouse, Association des Traumatisés du Crane et de la Face, Paris, France
- Study start
- 10 Jul 2012 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Jun 2012 (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.
Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. This interaction permit to make the hypothesis, that baseline brain activity is likely to shape our ongoing " stream of consciousness " and could correlate with conscious perception. The investigators hypothesized that DMN connectivity strength would be related to the level of consciousness of brain-damaged patients. The investigators will follow severely brain-injured patient in coma. Clinical examination using standardized behavioural scales: FOUR score (Full Outline of UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30 (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state between 30 and 60 days, an additional clinical and brain imaging assessment will be performed to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will be performed in patients by a senior anaesthesiologist throughout the experiment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coma patients | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will analyse DMN functional and anatomical connectivity in severely brain-injured patients in coma and during the first two month following brain injury. All patients will be admitted from one of the four Critical Care Units of University Teaching Hospital of Toulouse, France.
Key inclusion criteria (2 listed)
- Brain-damaged patients in coma (trauma or anoxic origin).
- Male and female, ranging in age from 18 to 75 years.
Key exclusion criteria (3 listed)
- Withdrawal of consent from the patients (or the persons having legal responsibility for them).
- Sedation or general anaesthesia during assessement period (< 24 hours).
- MRI contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injury
Time frame: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*)
To date, the functional significance of DMN resting state connectivity patterns remain unclear. We hypothesized that DMN connectivity strength would be related to the level of consciousness of non-communicative brain-damaged patients, as assessed by standardized behavioural scales (FOUR score, CRS-R). Furthermore, we expected that a disruption of functional connectivity in the DMN could predict brain-damaged patient's recovery.
1 secondary outcome
Compare functional and structural DMN connectivity between 1 and 2 month after severe brain injury
Time frame: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 32697504Peran P, Malagurski B, Nemmi F, Sarton B, Vinour H, Ferre F, Bounes F, Rousset D, Mrozeck S, Seguin T, Riu B, Minville V, Geeraerts T, Lotterie JA, Deboissezon X, Albucher JF, Fourcade O, Olivot JM, Naccache L, Silva S. Functional and Structural Integrity of Frontoparietal Connectivity in Traumatic and Anoxic Coma. Crit Care Med. 2020 Aug;48(8):e639-e647. doi: 10.1097/CCM.0000000000004406.
- Results publication: PubMed 27378806Rosazza C, Sattin D, Sebastiano DR, Minati L, Leonardi M, Silva S. Disruption of posteromedial large-scale neural communication predicts recovery from coma. Neurology. 2016 Jul 5;87(1):120-1. doi: 10.1212/WNL.0000000000002853. No abstract available.
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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.
Stein Silva, MD, PhD principal investigator
Inserm, Department of Anesthesiology and Critical Care at the University Teaching Hospital of Toulouse, France
Kader Boulanouar, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma, run by Institut National de la Santé Et de la Recherche Médicale, France 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Nov 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of DMN resting state fMRI connectivity between 1 and 2 month after severe brain injury (time frame: VISIT1 = coma state (an expected average of 3 to 30 days after brain injury), VISIT2 = recovery phase (an expected average of 30 to 60 days). Finally, in case of full recovery during the recovery phase an additional assessment will be performed (VISIT1*)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01620957, which also lists 2 linked publications.
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 18 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.