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Recruiting NCT03990558

Recovery of Consciousness Following Intracerebral Hemorrhage

— Observational Intra Cerebral Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intra Cerebral Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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. 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. 3. 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.

Primary outcome measures

  • Time to clinical command following [Time frame: Hospital discharge (approximately 3 weeks)]
  • Modified Rankin Scale (mRS) Score [Time frame: 6 months]
Secondary outcome measures (3)
  • 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • University of Miami and Jackson Health System (UM/JHS) — Miami
  • Columbia University Medical Center — New York

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: PMID 39443437

Identifiers

NCT: NCT03990558 · AAAS3574 · 1R01NS106014-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗