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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
BDH-Clinic Hessisch Oldendorf
Coordinator of this site? Confirm its status
Hessisch OldendorfGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.