NCT04445649 Prognostic Factors to Regain Consciousness
| NCT ID | NCT04445649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BDH-Klinik Hessisch Oldendorf |
| Condition | Neurologic Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2020-06-15 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2020-06-15 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation. In this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.
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
Contact & Investigator
Jens D Rollnik, MD
STUDY DIRECTOR
BDH-Clinic Hessisch Oldendorf
Frequently Asked Questions
Who can join the NCT04445649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Neurologic Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04445649 currently recruiting?
Yes, NCT04445649 is actively recruiting participants. Contact the research team at m.boltzmann@bdh-klinik-hessisch.oldendorf for enrollment information.
Where is the NCT04445649 trial being conducted?
This trial is being conducted at Hessisch Oldendorf, Germany.
Who is sponsoring the NCT04445649 clinical trial?
NCT04445649 is sponsored by BDH-Klinik Hessisch Oldendorf. The principal investigator is Jens D Rollnik, MD at BDH-Clinic Hessisch Oldendorf. The trial plans to enroll 130 participants.