Understanding recovery of consciousness after brain hemorrhage
Recovery of Consciousness Following Intracerebral Hemorrhage
This study is trying to see if certain brain responses can help predict how well people will recover after a brain hemorrhage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT03990558 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the timing of cognitive motor dissociation (CMD) in patients with intracerebral hemorrhage (ICH) and its implications for recovery. It will assess whether CMD can predict long-term functional outcomes and evaluate EEG responses to verbal commands in patients with and without sensory aphasia. By closely monitoring a homogenous cohort of ICH patients, the study seeks to clarify the trajectory of neurological recovery and improve prognostication. The study will involve 150 subjects over four years at two medical centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary intracerebral hemorrhage who are unresponsive to commands within 48 hours of the bleed.
Not a fit: Patients with major bleeding outside the specified brain regions or those with other acute brain injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools and recovery strategies for patients with intracerebral hemorrhage.
How similar studies have performed: Previous studies have indicated that cognitive motor dissociation may be linked to better recovery outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Miami, Florida and 1 other locations
- University of Miami and Jackson Health System (UM/JHS) — Miami, Florida, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jan Claassen, MD — Associate Professor of Neurology
- Study coordinator: Jan Claassen, MD
- Email: jc1439@cumc.columbia.edu
- Phone: 212-305-7236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.