Intra Cerebral HemorrhageRECONFIGNCT03990558
Recovery of Consciousness Following Intracerebral Hemorrhage
An observational study of Intra Cerebral Hemorrhage, run by Columbia University at 2 sites in United States.
Trial summary
The objectives of the RECONFIG clinical study are to : 1. To identify the time to the first diagnosis of cognitive motor dissociation (CMD) in intracerebral hemorrhage (ICH) patients and to investigate whether these patients will clinically follow commands earlier after the hemorrhage. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra Cerebral Hemorrhage
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2019to 31 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Unresponsive and responsive patients diagnosed with ICH.
Who may be able to join
- 18 years or older.
- Diagnosis of primary ICH (i.e., related to hypertension or anticoagulants) on Head CT and/or MRI in the frontal lobe, thalamus, or striatocapsular region.
- Unresponsive to commands within 48 hours after onset of the bleed.
- English, Spanish or, French as the primary language.
Who cannot join
- Major bleeding in the cortex outside of the frontal lobe, cerebellum, or brainstem (judged as a cause for unconsciousness as per the attending neurointensivist).
- Other causes of ICH or different types of acute brain injury (e.g., traumatic brain injury).
- Severe cardiorespiratory compromise and similar acutely life-threatening conditions at the time of enrollment.
- Evidence of pre-morbid aphasia or deafness.
- Unconscious prior to ICH.
- Pregnancy.
- Prisoners.
- Health care proxy decides against study participation or decided for withdrawal of life sustaining therapies.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Miami and Jackson Health System (UM/JHS)
Miami, Florida, 33136
Ayham Alkhachroum, MD, 305-243-6175, axa2610@med.miami.edu
Ayham Alkhachroum, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Jan Claassen, MD, 212-305-7236, jc1439@cumc.columbia.edu
Angela Velazquez, MD, 212-305-6071, agv2113@cumc.columbia.edu
About this study
The objectives of the RECONFIG clinical study are to :
- To identify the time to the first diagnosis of cognitive motor dissociation (CMD) in intracerebral hemorrhage (ICH) patients and to investigate whether these patients will clinically follow commands earlier after the hemorrhage.
- To determine whether CMD independently predicts long term functional outcomes (6-month mRS scores) in ICH patients, and is associated with long term cognitive and quality of life outcomes.
- To determine the EEG response to verbal commands of the motor imagery paradigm between patients with and without sensory aphasia.
The overall goal is to determine predictors and the trajectory of neurological recovery.
Read the detailed description
Unconsciousness is common after an acute brain injury such as a brain hemorrhage, and recovery is poorly understood. This lack of knowledge is a key impediment to the development of novel strategies to improve outcomes and is one of the main reasons that prognostication of recovery of consciousness and functional outcomes is inaccurate. One-fifth of clinically unconscious patients with acute brain injury are able to follow commands using a simple, bedside EEG motor imagery test that directly measures brain activity associated with the attempt to move. This state is called cognitive motor dissociation (CMD). Pilot data indicate that CMD patients are more likely to clinically recover consciousness and have better longterm functional outcomes than non-CMD patients. To integrate these findings into clinical practice, there is a need to better understand the trajectory of CMD. This will only be possible in a tightly-controlled study with a homogenous patient cohort that is well characterized early after the injury and captures long-term outcomes.
RECONFIG is a multicenter, prospective, cross-sectional observational study in patients who have a clinical diagnosis of intracerebral hemorrhage and that are unresponsive at the time of enrollment. One hundred and fifty subjects will be recruited over 4 years at 2 sites. Subjects will be assessed with behavioral measures and MRI during the acute hospitalization. Patients will be followed for 6 months to determine the functional outcome (primary outcome measure). Additionally, the investigator will study conscious intracerebral hemorrhage patients with intracerebral hemorrhage and aphasia to determine the impact of aphasia.
- Conditions
- Intra Cerebral Hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
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 |
|---|---|---|
| Primary ICH | Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical command following
To investigate whether patients will clinically follow commands earlier after the hemorrhage.
Measured: Hospital discharge (approximately 3 weeks)
Modified Rankin Scale (mRS) Score
A standardized interview that measures the degree of disability or dependence in the daily activities of people who have suffered causes of neurological disability. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Measured: 6 months
Secondary outcomes (3)
Quality of Life in Neurological Disorders (Neuro-QoL T-score)
Neuro-QoL is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The T-score is the standardized score with a mean of 50 and a standard deviation of 10.
For Neuro-QoL measures, higher scores equal more of the concept being measured (e.g., more Fatigue, more Lower Extremity Function - Mobility). Thus, a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
Measured: 6 months
Difference in EEG response rate to verbal commands of the motor imagery paradigm.
EEG response will be compared between patients with and without sensory aphasia.
Measured: 6 months
Modified Telephone Interview for Cognitive Status (TICS) score
A standardized test of cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical or inefficient. The 11 test items usually take less than 10 minutes to administer and score. All examinee responses are recorded verbatim. The individual item scores are summed to obtain the TICS Total score. The TICS Total score can be interpreted by means of four qualitative impairment ranges: Unimpaired, Ambiguous, Mildly Impaired, and Moderately to Severely Impaired.
TICS Total score provides a measure of global cognitive functioning and can be used to monitor changes in cognitive functioning over time. Higher score represents less cognitive impairment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start15 Jun 2019
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Jan Claassen, Columbia University
- Investigators
- Jan Claassen, MD, Principal investigator, Associate Professor of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990558
- Sponsor's protocol ID
- AAAS3574
- Other IDs
- 1R01NS106014-01A1
- Acronym
- RECONFIG
- Status last verified
- May 2026
- First submitted
- 17 Jun 2019
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heinonen GA, Carmona JC, Grobois L, Kruger LS, Velazquez A, Vrosgou A, Kansara VB, Shen Q, Egawa S, Cespedes L, Yazdi M, Bass D, Saavedra AB, Samano D, Ghoshal S, Roh D, Agarwal S, Park S, Alkhachroum A, Dugdale L, Claassen J. A Survey of Surrogates and Health Care Professionals Indicates Support of Cognitive Motor Dissociation-Assisted Prognostication. Neurocrit Care. 2025 Jun;42(3):786-793. doi: 10.1007/s12028-024-02145-5. Epub 2024 Oct 23.
PubMed 39443437
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Consciousness Following Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT03990558
- Acronym / sponsor ID
- RECONFIG / AAAS3574
- Conditions
- Intra Cerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 19 Jun 2019 (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 objectives of the RECONFIG clinical study are to :
- To identify the time to the first diagnosis of cognitive motor dissociation (CMD) in intracerebral hemorrhage (ICH) patients and to investigate whether these patients will clinically follow commands earlier after the hemorrhage.
- To determine whether CMD independently predicts long term functional outcomes (6-month mRS scores) in ICH patients, and is associated with long term cognitive and quality of life outcomes.
- To determine the EEG response to verbal commands of the motor imagery paradigm between patients with and without sensory aphasia.
The overall goal is to determine predictors and the trajectory of neurological recovery.
Detailed description
Unconsciousness is common after an acute brain injury such as a brain hemorrhage, and recovery is poorly understood. This lack of knowledge is a key impediment to the development of novel strategies to improve outcomes and is one of the main reasons that prognostication of recovery of consciousness and functional outcomes is inaccurate. One-fifth of clinically unconscious patients with acute brain injury are able to follow commands using a simple, bedside EEG motor imagery test that directly measures brain activity associated with the attempt to move. This state is called cognitive motor dissociation (CMD). Pilot data indicate that CMD patients are more likely to clinically recover consciousness and have better longterm functional outcomes than non-CMD patients. To integrate these findings into clinical practice, there is a need to better understand the trajectory of CMD. This will only be possible in a tightly-controlled study with a homogenous patient cohort that is well characterized early after the injury and captures long-term outcomes.
RECONFIG is a multicenter, prospective, cross-sectional observational study in patients who have a clinical diagnosis of intracerebral hemorrhage and that are unresponsive at the time of enrollment. One hundred and fifty subjects will be recruited over 4 years at 2 sites. Subjects will be assessed with behavioral measures and MRI during the acute hospitalization. Patients will be followed for 6 months to determine the functional outcome (primary outcome measure). Additionally, the investigator will study conscious intracerebral hemorrhage patients with intracerebral hemorrhage and aphasia to determine the impact of aphasia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary ICH | – | –Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresponsive and responsive patients diagnosed with ICH.
Key inclusion criteria (4 listed)
- 18 years or older.
- Diagnosis of primary ICH (i.e., related to hypertension or anticoagulants) on Head CT and/or MRI in the frontal lobe, thalamus, or striatocapsular region.
- Unresponsive to commands within 48 hours after onset of the bleed.
- English, Spanish or, French as the primary language.
Key exclusion criteria (8 listed)
- Major bleeding in the cortex outside of the frontal lobe, cerebellum, or brainstem (judged as a cause for unconsciousness as per the attending neurointensivist).
- Other causes of ICH or different types of acute brain injury (e.g., traumatic brain injury).
- Severe cardiorespiratory compromise and similar acutely life-threatening conditions at the time of enrollment.
- Evidence of pre-morbid aphasia or deafness.
- Unconscious prior to ICH.
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
Time to clinical command following
Time frame: Hospital discharge (approximately 3 weeks)
To investigate whether patients will clinically follow commands earlier after the hemorrhage.
Modified Rankin Scale (mRS) Score
Time frame: 6 months
A standardized interview that measures the degree of disability or dependence in the daily activities of people who have suffered causes of neurological disability. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
3 secondary outcomes
Quality of Life in Neurological Disorders (Neuro-QoL T-score)
Time frame: 6 months
Difference in EEG response rate to verbal commands of the motor imagery paradigm.
Time frame: 6 months
Modified Telephone Interview for Cognitive Status (TICS) score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 39443437Heinonen GA, Carmona JC, Grobois L, Kruger LS, Velazquez A, Vrosgou A, Kansara VB, Shen Q, Egawa S, Cespedes L, Yazdi M, Bass D, Saavedra AB, Samano D, Ghoshal S, Roh D, Agarwal S, Park S, Alkhachroum A, Dugdale L, Claassen J. A Survey of Surrogates and Health Care Professionals Indicates Support of Cognitive Motor Dissociation-Assisted Prognostication. Neurocrit Care. 2025 Jun;42(3):786-793. doi: 10.1007/s12028-024-02145-5. Epub 2024 Oct 23.
Related trials for Intra Cerebral Hemorrhage
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
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.
Jan Claassen, MD principal investigator
Associate Professor of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra Cerebral Hemorrhage, run by Columbia University at 2 sites 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Claassen, MD (212-305-7236, jc1439@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical command following (time frame: Hospital discharge (approximately 3 weeks)). The study lists 2 primary outcomes in all. 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 NCT03990558, which also lists 1 linked publication.
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 13 May 2026.