A Phase 4 interventional study of Cerebrolysin and Control in Disorder of Consciousness and Hemorrhagic Stroke, sponsored by Konkuk University Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Treatment
Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.
Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury
Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV
Comparison: cerebrolysin group versus control group
Outcome: Coma Recovery Scale-revised, FDG-PET signal
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 12 is below the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
Drug: Cerebrolysin
100 ml normal saline, days 4-17, once/day, IV
Drug: Control
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
100 ml normal saline, days 4-17, once/day, IV
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Time frame: 2 days after randomization
Coma Recovery Scale - revised
Assessing the degree of disorders of consciousness
Time frame: 17 days after randomization
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Time frame: 2 days after randomization
Positron Emitting Tomography
Assessing the degree of brain neural network activity
Time frame: 17 days after randomization
Plan to share: No
Started Jun 2023 (actual). Primary completion is estimated for Sep 2026, 39 months after the start.
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Studies of the drug tested here: Cerebrolysin
Konkuk University Medical Center