Recruiting

EEG & Brain Recovery

Sponsor:

Columbia University

Code:

NCT07794605

Conditions

Traumatic Brain Injury (TBI) Patients

Intracerebral Hemorrhage (ICH)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Severe brain injuries can leave people in states where they are unconscious or only partly aware, such as a coma. These conditions are common after injuries like head trauma or bleeding in the brain. One of the biggest challenges for doctors is knowing if - or when - a patient will wake up and regain awareness.

This research study is being done to determine if patterns in brain activity during sleep (measured by EEG) can help doctors better predict how quickly someone will wake up and recover after a serious brain injury, as well as how well they might do in the long term. It also aims to develop new ways of using EEG to track how the brain's networks heal and reconnect over time.

Conditions

Traumatic Brain Injury (TBI) Patients

Intracerebral Hemorrhage (ICH)

Study ID

NCT07794605

Start date

Oct 30, 2026

Status verified date

Oct, 2026

Completion date

Oct 30, 2031

Anticipated

Primary completion date

Oct 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Adults with non-penetrating traumatic brain injury (TBI) or with primary intracerebral hemorrhage (ICH) (i.e. from hypertension or anticoagulants) who remain behaviorally unresponsive to verbal commands (i.e., comatose vegetative state, or minimally conscious state minus \[MCS-minus, defined as unresponsive with preserved visual fixation/pursuit or localization to noxious stimuli\]) by day 2 after injury

Exclusion Criteria:

  • Evidence of consciousness within 2 days of injury
  • Uncontrolled seizures
  • pre-existing disorders of consciousness
  • deafness

Study Design

Enrollment

230 participants

Anticipated

Interventions and Outcome Measures

Arms

Intracerebral Hemorrhage and Traumatic Brain Injury

Adult patients with acute neurological injury with Disorders of Consciousness (traumatic brain injury, and intracerebral hemorrhage).

Primary outcome measure

  • P-value for prediction of the detection of cognitive motor dissociation (CMD) [ Time Frame: Day 9 ]
  • Prediction of recovery of consciousness by day 28 after brain injury [ Time Frame: Day 28 ]
  • Sleep as a prognosticator of long-term independence and disability after traumatic brain injury (TBI) [ Time Frame: 12 months post injury ]
  • Sleep as a prognosticator of long-term disability after intracerebral hemorrhage (ICH) [ Time Frame: 12 months post injury ]

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

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Jan Claassen, MD

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

Principal Investigator:

Jan Claassen, MD

More Information

Sponsor

Columbia University

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • cognitive motor dissociation (CMD)
  • Disorders of Consciousness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Columbia University on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.