NCT03990558

Brief Summary

The objectives of the RECONFIG clinical study are to :

  1. 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. 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. 3.To determine the EEG response to verbal commands of the motor imagery paradigm between patients with and without sensory aphasia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

6.8 years

First QC Date

June 17, 2019

Last Update Submit

May 5, 2025

Conditions

Intra Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • Time to clinical command following

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

    Hospital discharge (approximately 3 weeks)

  • Modified Rankin Scale (mRS) Score

    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.

    6 months

Secondary Outcomes (3)

  • Quality of Life in Neurological Disorders (Neuro-QoL T-score)

    6 months

  • Difference in EEG response rate to verbal commands of the motor imagery paradigm.

    6 months

  • Modified Telephone Interview for Cognitive Status (TICS) score

    6 months

Study Arms (1)

Primary ICH

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Unresponsive and responsive patients diagnosed with ICH.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Miami, Florida, 33136, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Claassen, MD

    Associate Professor of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Claassen, MD

CONTACT

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

Angela Velazquez, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 19, 2019

Study Start

June 15, 2019

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

May 7, 2025

Record last verified: 2025-05

Locations

US(2)