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Treating severe brain-injured patients with apomorphine : a behavioural and neuroimaging study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504631-40-01
Enrollment
102
Registered
2024-09-16
Start date
2018-09-05
Completion date
Unknown
Last updated
2025-07-24

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

Conditions

Disorder of Consciousness, severe brain injury

Brief summary

Change of diagnosis from baseline in Coma Recovery Scale - Revised (CRS-R)

Detailed description

Change of total score in Nociception Coma Scale - Revised (NCS-R), Changes in EEG spectral power within fixed bands or dynamic connectivity using median spectral connectivity and graph-theoretic topology metrics, Changes in the probabilty of consciousness using a multivariate EEG classifier based on a machine-learning approach using 120 EEG markers, Changes in quantification of PET signal using standardized uptake values of fluorodeoxyglucose, Changes in MRI functional connectivity using a seed-voxel approach, between regions of interest (here: striatum, globus pallidus interna, thalamus and prefrontal cortex) and the time course from all other brain voxels, Change in circadian rhythmicity using actimetry and body temperature variations, Change in the architecture of sleep cycles using night EEG, Change of score in Glasgow Outcome Scale - Extended (GOS-E), Change in diagnosis in Phone-adapted CRS-R

Interventions

DRUG9%
DRUGApomorphine hydrochloride 5 mg/ml

Sponsors

Universite De Liege, CHU De Liege
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change of diagnosis from baseline in Coma Recovery Scale - Revised (CRS-R)

Secondary

MeasureTime frame
Change of total score in Nociception Coma Scale - Revised (NCS-R), Changes in EEG spectral power within fixed bands or dynamic connectivity using median spectral connectivity and graph-theoretic topology metrics, Changes in the probabilty of consciousness using a multivariate EEG classifier based on a machine-learning approach using 120 EEG markers, Changes in quantification of PET signal using standardized uptake values of fluorodeoxyglucose, Changes in MRI functional connectivity using a seed-voxel approach, between regions of interest (here: striatum, globus pallidus interna, thalamus and prefrontal cortex) and the time course from all other brain voxels, Change in circadian rhythmicity using actimetry and body temperature variations, Change in the architecture of sleep cycles using night EEG, Change of score in Glasgow Outcome Scale - Extended (GOS-E), Change in diagnosis in Phone-adapted CRS-R

Countries

Belgium, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026