Assessing recovery potential in patients with consciousness disorders
Multimodal Neuroprognostication in Disorders of Consciousness
This study is trying to see how well patients with brain injuries who have disorders of consciousness can recover by looking at their behavior, brain activity, and brain scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04534777 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with disorders of consciousness resulting from brain injuries. It aims to improve the understanding of recovery potential through a multimodal approach that includes behavioral assessments, neurophysiological evaluations, and advanced neuroimaging techniques. By analyzing these various markers, the study seeks to provide more accurate prognostic information for patients in different states of consciousness. The ultimate goal is to enhance medical management and decision-making for these critically ill patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with acute, sub-acute, or chronic consciousness disorders due to brain injuries.
Not a fit: Patients who are deeply sedated or have severe neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of recovery in patients with consciousness disorders, improving their care and management.
How similar studies have performed: While multimodal assessments are recommended, the predictive values of these markers are not well understood, indicating that this approach is novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery) 2. Brain injuries on CT or MRI (e.g. TBI) (traumatic brain-injured ), anoxia or stroke related lesions, etc…) 3. Age between 18 and 80 years Exclusion Criteria: 1. Deep sedation (e.g. elevated ICP(intracranial pressure ), refractory status epilepticus) 2. Sever known neurodegenerative disease (e.g. Alzheimer disease) 3. Pregnancy
Where this trial is running
Paris
- Hôpital Pitié Salpétrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Benjamin ROHAUT, MD
- Email: benjamin.rohaut@aphp.fr
- Phone: 184827888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.