Understanding recovery of consciousness after brain hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Maximal Medical Care for Intracerebral Hemorrhage (ICH) – Pilot

  This pilot test checks whether a maximal medical care bundle for ICH patients is feasible and safe to use in the first 72 hours.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT06648369

• Understanding the impact of brain swelling in stroke patients

  This study is trying to understand how brain swelling affects people who have had a severe type of stroke to see if it can help improve their treatment.

  Recruiting University Hospital, Lille · Lille · NCT04621357

• Minimally invasive treatment for brain hemorrhage compared to standard care

  This study is testing a new, less invasive treatment for brain bleeding to see if it works better than standard care for patients who arrive at the emergency room with a significant hemorrhage.

  Recruiting at 7 sites University of Melbourne · Newcastle, New South Wales and 12 other locations · NCT04434807

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.