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Observational Study on Recovery of Consciousness After Intracerebral Hemorrhage

This observational study, RECONFIG, is looking at how people recover consciousness after an intracerebral hemorrhage (ICH), which is bleeding inside the brain. Researchers want to understand why some patients who are unresponsive to commands can still show brain activity when asked to move, a state called cognitive motor dissociation (CMD). They will observe 150 adults who have had an ICH and are unresponsive within 48 hours of the bleed. The study aims to see if CMD helps predict when someone will start following commands and how well they recover over six months. This research will help doctors better understand and predict recovery after a brain bleed.

Study design
This is a multicenter, prospective, cross-sectional observational study. It plans to enroll 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' recovery will be assessed at hospital discharge (around 3 weeks) and their functional outcomes will be measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03990558

Recovery of Consciousness Following Intracerebral Hemorrhage

Recruiting
Not specifiedAges 18+Observational
Columbia University
~150 participants
Updated 2026-05-13 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to clinical command following
Measured over Hospital discharge (approximately 3 weeks)
+1 more outcome measured

Conditions

Intra Cerebral Hemorrhage

Explore related trials

Cerebral Hemorrhage

Where it's being run

2 sites across 2 states
Florida1
New York1

Study leadership

  • Jan Claassen, MD · PRINCIPAL_INVESTIGATOR · Associate Professor of Neurology

Who to contact

Jan Claassen, MD
[email protected]
212-305-7236
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Time to clinical command followingHospital discharge (approximately 3 weeks)

    To investigate whether patients will clinically follow commands earlier after the hemorrhage.

  • Modified Rankin Scale (mRS) Score6 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.