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Neurophysiological hallmarks and predictors in disorders of consciousness

Neurophysiological hallmarks and predictors in disorders of consciousness

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022523
Enrollment
60
Registered
2020-12-27
Start date
2021-01-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mimimal conscious state G93.80

Interventions

Group 1: 1. Standardized clinical assessment: a. Coma recovery scale (CRS-R): the reaction to diverse stimuli and the spontaneous behavior of the patients will be recorded in the standardized clinical
: During a MRI examination structural brain lesions and the fiber connections of the brain (DTI) are documented
a functional resting state fMRI is applied to assess the resting activity of the brain b. Event related potentials (ERP) The electro-encephalogram is recorded during the patients hear correct or incor
the MRI and the ERP will be assessed as well as the behavioural data (CRS-R, five times) within a 14-day period.

Sponsors

Geschäftsführerin der gemeinnützigen Stiftung Schmieder für Wissenschaft und Forschung;Lurija Institut für Rehabilitationswissenschaften und Gesundheitsforschung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: - Patients with severe disorders of consciousness and loss of ability to communicate - Type of brain injury/damage: traumatic brain injury, hypoxia, cerebral infarct/bleeding/ subarachnoid hemorrhage, intoxication - Initial examination within a maximum period of 6 month after injury - Legal guardian/representative of the patient give the written informed consent to the study following the principles and guidelines of the Declaration of Helsinki

Exclusion criteria

Exclusion criteria: - contraindication for MRI - bilateral craniectomy - severe extended lesion of the cerebral cortex, e.g. > 2/3 middle cerebral artery territory

Design outcomes

Primary

MeasureTime frame
regaining the reliable ability to communicate

Secondary

MeasureTime frame
- result of the fMRI resting state analysis according to the protocol of Demertzi with differentiation between MCS/UWS - positive N400 in the ERP

Countries

Germany

Contacts

Public ContactThomas Hassa

Lurija Institut für Rehabilitationswissenschaften und Gesundheitsforschung

t.hassa@kliniken-schmieder.de0049-7533-808-1403

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026