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Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State) | Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

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

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Implantable neurostimulation system

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

deep brain stimulation

Study Status

Unknown status

Start Date: April 2012

Completed Date: November 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: CRS-R scores (Coma Recovery Scale-Revised)

Secondary Outcome: signs of awakening at night

Study sponsors, principal investigator, and references

Principal Investigator: Jean-Jacques LEMAIRE

Lead Sponsor: University Hospital, Clermont-Ferrand

Collaborator: Fondation de l'Avenir

More information:https://clinicaltrials.gov/show/NCT01718249

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