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

University Hospital, Clermont-Ferrand

Status: Completed

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

Treatments: Other: Implantable neurostimulation system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01718249

2011-A00300-41

CHU-0126

Details and patient eligibility

About

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.

Full description

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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5 participants in 1 patient group

deep brain stimulation

Other group

Treatment:

Other: Implantable neurostimulation system