Status:
ACTIVE_NOT_RECRUITING
Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness
Lead Sponsor:
University of Liege
Conditions:
Consciousness Disorder
Minimally Conscious State
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders of consciousness. Notably, a case reported improvement of level of consciousness using trans...
Detailed Description
Currently, therapeutic options for severely brain-injured patients with disorders of consciousness (DOC), including patients in unresponsive wakefulness syndrome (UWS) and minimally conscious state (M...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- State of consciousness: unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) as defined by CRS-R performed during the screening period.
- Cerebral damage of known etiology
- Time since injury between 7 and 90 days
- Intact skin at the ears
- Consent given by the substitute decision maker
Exclusion
- Anyone who is deemed medically unsuitable for this study as determined by a physician involved with the study (e.g. severe rythmic heart condition)
- Previous history of neurological disorders
- Documented pregnancy
- Active implant (i.e. pacemaker)
- Profound sedation such as one caused by general anaesthetics (e.g., propofol) or a combination of central acting sedatives (e.g., benzodiazepines, opioids)
Key Trial Info
Start Date :
February 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04065386
Start Date
February 9 2022
End Date
December 21 2024
Last Update
November 22 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium, 1340
2
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000