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

Not Applicable

Completed

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

• Registration Number: NCT01718249
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-10-31
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CRS-R scores (Coma Recovery Scale-Revised)	after 2 months and after 7 months

Secondary Outcome Measures

Name	Time	Method
signs of awakening at night	during the 10 months of the study
zerit burden interview	at 1 month and at 10 months

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France