Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT03990558

Conditions

Intra Cerebral Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.

Conditions

Intra Cerebral Hemorrhage

Study ID

NCT03990558

Start date

Jun 15, 2019

Status verified date

May, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Mar 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary ICH

Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jan Claassen, MD

212-305-7236jc1439@cumc.columbia.edu

Angela Velazquez, MD

212-305-6071agv2113@cumc.columbia.edu

Locations

University of Miami and Jackson Health System (UM/JHS)

Recruiting

Miami, Florida, United States, 33136

Contacts

Ayham Alkhachroum, MD

305-243-6175axa2610@med.miami.edu

Principal Investigator:

Ayham Alkhachroum, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Jan Claassen, MD

212-305-7236jc1439@cumc.columbia.edu

Angela Velazquez, MD

212-305-6071agv2113@cumc.columbia.edu

Principal Investigator:

Jan Claassen, MD

More Information

Sponsor

Columbia University

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-13.