NCT04445649Recruiting
Prognostic Factors to Regain Consciousness
Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 18 Jun 2020
- Start date
- 15 Jun 2020
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Diseases
- Stroke
- NCT number
- NCT04445649
What you commit to
- Study type: Observational
- Planned participants: 130
- From 15 Jun 2020 to the primary completion date, 15 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous brain damage
Other illness
- mental disorders (dementia, depression)
Other
- insufficient cardiorespiratory stability
- fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials
- colonization with multi-resistant pathogens
- MRI contraindications
- claustrophobia
- weight \> 120 kg
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BDH-Clinic Hessisch Oldendorf Coordinator of this site? Confirm its status | Hessisch Oldendorf | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.