Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)
Conditions
Keywords
Deep Brain Stimulation (DBS), Post-coma, Consciousness, Vegetative state, Minimally conscious state
Brief summary
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.
Detailed description
Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).
Interventions
OTHERImplantable neurostimulation system
Sponsors
University Hospital, Clermont-Ferrand
Fondation de l'Avenir
Medtronic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.
Exclusion criteria
* Cerebral death, Locked-In Syndrome, blindness, deafness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRS-R scores (Coma Recovery Scale-Revised) | after 2 months and after 7 months |
Secondary
| Measure | Time frame |
|---|---|
| signs of awakening at night | during the 10 months of the study |
| zerit burden interview | at 1 month and at 10 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-Jacques LEMAIRE
University Hospital, Clermont-Ferrand
Outcome results
None listed