Prognostic Factors to Regain Consciousness
Launched by BDH-KLINIK HESSISCH OLDENDORF · Jun 23, 2020
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying patients with disorders of consciousness (DOC), which can occur after conditions like traumatic brain injury, stroke, or lack of oxygen to the brain. The main goal is to identify factors that can predict how well these patients will recover over time. Researchers will include 130 patients who are starting early rehabilitation. They will gather important information about each patient's condition and brain function right after they begin treatment and continue to check their progress weekly for up to a year.
To be eligible for this study, patients must be at least two weeks post-injury and have been admitted to the intensive care unit with a disorder of consciousness, such as being in a coma or having very limited awareness. Participants will undergo various tests, including brain scans and monitoring of brain activity, to help doctors understand their recovery potential better. It’s important to note that certain medical conditions or situations, like pregnancy or severe heart and lung issues, could prevent someone from participating. Overall, this study aims to provide valuable insights that could improve rehabilitation and outcomes for patients facing these challenging conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • early neurological rehabilitation (phase B)
- • stroke, traumatic brain injury, hypoxic-ischemic encephalopathy
- • disorder of consciousness (coma, UWS, MCS)
- • at minimum two weeks after disease onset
- • admission to intensive care unit
- • written consent from the patient's legal representative
- • exclusion of pregnancy
- Exclusion Criteria:
- • insufficient cardiorespiratory stability
- • fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials
- • previous brain damage
- • mental disorders (dementia, depression)
- • colonization with multi-resistant pathogens
- • MRI contraindications
- • claustrophobia
- • weight \> 120 kg
About Bdh Klinik Hessisch Oldendorf
BDH-Klinik Hessisch Oldendorf is a distinguished clinical trial sponsor dedicated to advancing medical research and improving patient care. Located in Hessisch Oldendorf, Germany, the clinic specializes in innovative treatments and therapies across various medical fields. With a commitment to high-quality standards and ethical practices, BDH-Klinik collaborates with healthcare professionals and research institutions to conduct rigorous clinical trials that aim to enhance therapeutic options and patient outcomes. Their focus on patient safety and scientific integrity underscores their role as a trusted partner in the clinical research community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hessisch Oldendorf, , Germany
Patients applied
Trial Officials
Jens D Rollnik, MD
Study Director
BDH-Clinic Hessisch Oldendorf
Melanie Boltzmann, PhD
Principal Investigator
BDH-Clinic Hessisch Oldendorf
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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