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Complexity-enhancing drugs to treat disorders of consciousness (DoC): a ketamine study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518433-29-00
Acronym
V1ComplexitDOC
Enrollment
40
Registered
2024-10-08
Start date
2022-01-01
Completion date
Unknown
Last updated
2025-09-05

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

New signs of consciousness (e.g., response to command) measured by the SECONDs., Brain complexity measured by LZC and/or PCI in the ketamine session at the highest dose, compared to placebo and the baseline.

Detailed description

The “additional index” (from 0 to 100) of the SECONDs, Baseline fMRI activity in the fronto-parietal network and the thalamo-cortical loop, Baseline metabolic PET level in the fronto-parietal network and the thalamo-cortical loop, EEG alpha connectivity measured via alpha centrality, Spasticity measured via the Modified Ashworth Score, Spasticity measured via EMG recording (H/M ratio), Range of Motion

Interventions

DRUGKetalar 10mg/ml Solution for Injection/Infusion

Sponsors

Universite De Liege, Centre Hospitalier Universitaire De Liege
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
New signs of consciousness (e.g., response to command) measured by the SECONDs., Brain complexity measured by LZC and/or PCI in the ketamine session at the highest dose, compared to placebo and the baseline.

Secondary

MeasureTime frame
The “additional index” (from 0 to 100) of the SECONDs, Baseline fMRI activity in the fronto-parietal network and the thalamo-cortical loop, Baseline metabolic PET level in the fronto-parietal network and the thalamo-cortical loop, EEG alpha connectivity measured via alpha centrality, Spasticity measured via the Modified Ashworth Score, Spasticity measured via EMG recording (H/M ratio), Range of Motion

Countries

Belgium

Outcome results

None listed

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