Consciousness DisorderRESPONSE 2NCT03504709
REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
An observational study of Consciousness Disorder and Coma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Consciousness Disorder, Coma, Brain Injuries, Traumatic
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 23 Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults admitted to the intensive care unit for acute severe traumatic brain injury
Who may be able to join
- Traumatic Brain Injury
- Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness
- Clinical evidence of disorder of consciousness defined as coma, VS, or MCS
Who cannot join
- History of prior severe brain injury or dementia
- Emergence from MCS at time of initial CRS-R assessment
- Healthy Subjects:
- History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Advanced MRI and EEG to Predict Recovery of Consciousness After Severe Traumatic Brain Injury
The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).
- Conditions
- Consciousness Disorder, Coma, Brain Injuries, Traumatic
- Medical subject headings
- Consciousness Disorders, Coma, Brain Injuries, Traumatic
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 |
|---|---|---|
| Patient (n=50) | Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post injury. | |
| Healthy (n=25) | Healthy adults with no neurological, psychiatric, or medical disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Rating Scale total score
The Disability Rating Scale (DRS) provides quantitative information regarding functional disability in patients recovering from severe brain injury. The total score on the DRS ranges from 0 to 29 with higher scores indicating a greater degree of disability. DRS subscale scores include eye opening [score range 0-3], communication [score range 0-4], motor response [score range 0-5], cognitive ability for feeding [score range 0-3], cognitive ability for toileting [score range 0-3], cognitive ability for grooming [score range 0-3], level of function [score range 0-5], and employability [score range 0-3]. Subscale scores are summed to produce the total score.
Measured: 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start5 Sep 2018
- Primary completion19 Jul 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Consciousness DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian L. Edlow, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504709
- Sponsor's protocol ID
- 2012P000784
- Acronym
- RESPONSE 2
- Status last verified
- Aug 2024
- First submitted
- 20 Mar 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Edlow BL, Chatelle C, Spencer CA, Chu CJ, Bodien YG, O'Connor KL, Hirschberg RE, Hochberg LR, Giacino JT, Rosenthal ES, Wu O. Early detection of consciousness in patients with acute severe traumatic brain injury. Brain. 2017 Sep 1;140(9):2399-2414. doi: 10.1093/brain/awx176.
PubMed 29050383Bodien YG, Giacino JT, Edlow BL. Functional MRI Motor Imagery Tasks to Detect Command Following in Traumatic Disorders of Consciousness. Front Neurol. 2017 Dec 18;8:688. doi: 10.3389/fneur.2017.00688. eCollection 2017.
PubMed 29326648Bodien YG, Chatelle C, Edlow BL. Functional Networks in Disorders of Consciousness. Semin Neurol. 2017 Oct;37(5):485-502. doi: 10.1055/s-0037-1607310. Epub 2017 Dec 5.
PubMed 29207410Threlkeld ZD, Bodien YG, Rosenthal ES, Giacino JT, Nieto-Castanon A, Wu O, Whitfield-Gabrieli S, Edlow BL. Functional networks reemerge during recovery of consciousness after acute severe traumatic brain injury. Cortex. 2018 Sep;106:299-308. doi: 10.1016/j.cortex.2018.05.004. Epub 2018 May 12.
PubMed 29871771Olchanyi MD, Augustinack J, Haynes RL, Lewis LD, Cicero N, Li J, Destrieux C, Folkerth RD, Kinney HC, Fischl B, Brown EN, Iglesias JE, Edlow BL. Automated MRI Segmentation of Brainstem Nuclei Critical to Consciousness. Hum Brain Mapp. 2025 Oct 1;46(14):e70357. doi: 10.1002/hbm.70357.
PubMed 41074651
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MRI and EEG to Predict Recovery of Consciousness After Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03504709
- Acronym / sponsor ID
- RESPONSE 2 / 2012P000784
- Conditions
- Consciousness Disorder, Coma, Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 20 Apr 2018 (actual)
- 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 aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient (n=50) | – | –Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post injury. |
| Healthy (n=25) | – | –Healthy adults with no neurological, psychiatric, or medical disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the intensive care unit for acute severe traumatic brain injury
Key inclusion criteria (3 listed)
- Traumatic Brain Injury
- Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness
- Clinical evidence of disorder of consciousness defined as coma, VS, or MCS
Key exclusion criteria (4 listed)
- History of prior severe brain injury or dementia
- Emergence from MCS at time of initial CRS-R assessment
- History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease
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
Disability Rating Scale total score
Time frame: 6 months post injury
The Disability Rating Scale (DRS) provides quantitative information regarding functional disability in patients recovering from severe brain injury. The total score on the DRS ranges from 0 to 29 with higher scores indicating a greater degree of disability. DRS subscale scores include eye opening [score range 0-3], communication [score range 0-4], motor response [score range 0-5], cognitive ability for feeding [score range 0-3], cognitive ability for toileting [score range 0-3], cognitive ability for grooming [score range 0-3], level of function [score range 0-5], and employability [score range 0-3]. Subscale scores are summed to produce the total score.
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 21 Aug 2024.
- Background: PubMed 29050383Edlow BL, Chatelle C, Spencer CA, Chu CJ, Bodien YG, O'Connor KL, Hirschberg RE, Hochberg LR, Giacino JT, Rosenthal ES, Wu O. Early detection of consciousness in patients with acute severe traumatic brain injury. Brain. 2017 Sep 1;140(9):2399-2414. doi: 10.1093/brain/awx176.
- Background: PubMed 29326648Bodien YG, Giacino JT, Edlow BL. Functional MRI Motor Imagery Tasks to Detect Command Following in Traumatic Disorders of Consciousness. Front Neurol. 2017 Dec 18;8:688. doi: 10.3389/fneur.2017.00688. eCollection 2017.
- Background: PubMed 29207410Bodien YG, Chatelle C, Edlow BL. Functional Networks in Disorders of Consciousness. Semin Neurol. 2017 Oct;37(5):485-502. doi: 10.1055/s-0037-1607310. Epub 2017 Dec 5.
- Background: PubMed 29871771Threlkeld ZD, Bodien YG, Rosenthal ES, Giacino JT, Nieto-Castanon A, Wu O, Whitfield-Gabrieli S, Edlow BL. Functional networks reemerge during recovery of consciousness after acute severe traumatic brain injury. Cortex. 2018 Sep;106:299-308. doi: 10.1016/j.cortex.2018.05.004. Epub 2018 May 12.
- Derived from this study: PubMed 41074651Olchanyi MD, Augustinack J, Haynes RL, Lewis LD, Cicero N, Li J, Destrieux C, Folkerth RD, Kinney HC, Fischl B, Brown EN, Iglesias JE, Edlow BL. Automated MRI Segmentation of Brainstem Nuclei Critical to Consciousness. Hum Brain Mapp. 2025 Oct 1;46(14):e70357. doi: 10.1002/hbm.70357.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Consciousness Disorder and Coma, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 4 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 21 Aug 2024. 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 United States. 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?
Disability Rating Scale total score (time frame: 6 months post injury). 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 NCT03504709, which also lists 5 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 21 Aug 2024.