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Search / Trial NCT04445649

Prognostic Factors to Regain Consciousness

Launched by BDH-KLINIK HESSISCH OLDENDORF · Jun 23, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Neurological Rehabilitation Prognosis Outcome Level Of Consciousness

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.

Locations

Hessisch Oldendorf, , Germany

Patients applied

0 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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