Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State) Clinical Trial
— Post-coma DBSOfficial title:
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
| Verified date | November 2017 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | Fondation de l'Avenir, Medtronic |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CRS-R scores (Coma Recovery Scale-Revised) | after 2 months and after 7 months | ||
| Secondary | signs of awakening at night | during the 10 months of the study | ||
| Secondary | zerit burden interview | at 1 month and at 10 months |