Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

University Hospital, Clermont-Ferrand5 enrolled

Overview

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.

Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

CRS-R scores (Coma Recovery Scale-Revised)

Time frame: after 2 months and after 7 months

Secondary Outcomes

signs of awakening at night

Time frame: during the 10 months of the study

zerit burden interview

Time frame: at 1 month and at 10 months