Identifying factors that predict recovery of consciousness in brain injury patients
Official title: Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation
Run by BDH-Klinik Hessisch Oldendorf · NCT04445649 · Data updated 2026-11-12
This study is trying to find out what factors help predict how well patients with brain injuries will recover their awareness after they start early rehabilitation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | BDH-Klinik Hessisch Oldendorf Academic / other |
| Locations | 1 site (Hessisch Oldendorf) |
| Status | Recruiting |
| Started | June 15, 2020 |
| Main results expected | June 15, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT04445649 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with disorders of consciousness due to stroke, traumatic brain injury, or hypoxic-ischemic encephalopathy who are at least two weeks post-onset and have been admitted to an intensive care unit.
✕Probably not a fit
Patients with insufficient cardiorespiratory stability, severe brain injuries affecting auditory responses, or those with mental disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify prognostic factors that influence the medium and long-term outcomes of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation. A total of 130 patients will be included over 36 months, with assessments of disease severity, functional status, and various neurological measurements such as MRI and EEG conducted within the first week of admission. The primary outcome will be measured using the Coma-Recovery-Scale-Revised, with follow-ups at 3, 6, and 12 months to evaluate recovery using the Glasgow Outcome Scale-Revised. The study seeks to enhance understanding of recovery patterns in patients with DOC following severe brain injuries.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the factors that enhance recovery of consciousness, leading to improved treatment strategies for patients with severe brain injuries.
How similar studies have gone: While there have been numerous studies on prognostic factors in similar conditions, this specific approach focusing on early rehabilitation outcomes in DOC patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, Germany Recruiting
Study contacts
- Principal investigator: Melanie Boltzmann, PhD — BDH-Clinic Hessisch Oldendorf
- Study coordinator: Melanie Boltzmann, PhD
- Email: m.boltzmann@bdh-klinik-hessisch.oldendorf
- Phone: 0049 5152 781 256
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.