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Completed
NCT01718249
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
Conditions: Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 5
Sponsor: University Hospital, Clermont-Ferrand
Location: CHU Clermont-Ferrand Clermont-Ferrand
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT01718249). StuddyBuddy aggregates publicly available trial information.
