Recovery Trajectory for Coma and Disorders of Consciousness (NCT07614074) | Clinical Trial Compass
RecruitingNot Applicable
Recovery Trajectory for Coma and Disorders of Consciousness
United States2,000 participantsStarted 2023-09-26
Plain-language summary
This study aims to better understand recovery after coma caused by serious neurologic illness or injury. Patients who are unconscious (in a coma or disorder of consciousness) due to conditions such as stroke, cardiac arrest, traumatic brain injury, seizures, brain infection, or other neurologic emergencies may be enrolled during their hospitalization.
The purpose of this observational research study is to learn which medical, neurologic, psychological, and social factors are associated with recovery over time. Researchers will collect information from the medical record during hospitalization, including details about the patient's illness, treatments received, brain imaging, and neurologic examinations.
For patients who survive hospitalization, the study team will contact participants or their caregivers after discharge to assess recovery at scheduled time points using questionnaires and structured interviews about physical function, quality of life, emotional well-being, and daily activities.
This study does not assign participants to any experimental treatment. Participation will not change the medical care patients receive. Information learned from this study may help improve future care for patients with coma and disorders of consciousness.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age greater than or equal to 18 years on the day of hospital admission
* Coma duration of at least 24 hours from presentation to the receiving hospital, or died prior to the 24 hour timepoint without return of consciousness. Coma defined as: GCS score of less than or equal to 10 AND GCS score of less than 6 on the motor component of the GCS(not following commands) AND GCS score less than 3 on the verbal component AND alteration of consciousness not explained by sedation only
* Coma due to a neurological process (Including but not limited to: trauma, stroke, hypoxic- ischemic brain injury (HIBI), CNS infection, seizure, other processes at the discretion of the investigator)
* Admission to the intensive care unit, or deceased prior to admission.
Exclusion Criteria:
* Pre-existing score of 5 or less on the motor component of the Glasgow Coma Scale prior to hospital admission.
* Transfer from another acute care hospital in which the motor component of the Glasgow Coma Scale on the day after initial hospital arrival is not known or cannot be reconstructed from medical records or history.
* Coma due to sepsis, systemic metabolic processes (ex: organ failure or sedation).
* GCS score of greater than 2 for eye opening with lack of command following due to a focal brain lesion causing receptive aphasia.
* Prisoner
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is observational and tracks recovery over time using something called the Modified Rankin Scale — does that mean it's measuring disability and functional outcomes, and would participating involve any treatments or just assessments and follow-up visits?
2Since this trial enrolls people with very different causes of impaired consciousness — like cardiac arrest, traumatic brain injury, stroke, and meningitis — how does my specific diagnosis affect what my participation would actually look like, and whether the findings would be relevant to my situation?
3Given that the recruitment status is active and this appears to be a non-interventional study, would joining this trial interfere in any way with the standard care or treatment decisions I'd otherwise be receiving for my condition?
4Because disorders of consciousness can involve patients who may not be able to give consent themselves, what are the rules around consent in this trial, and how would my family or I be involved in that decision?
5What does the Modified Rankin Scale actually measure in terms of recovery, and would the assessments happen over a long period of time — and is that level of follow-up realistic given my current situation and caregiving demands?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Rankin Scale (mRS)
Timeframe: 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, and 48 months after coma onset, with continued assessments at 6-month intervals thereafter until study completion