Back to resultsStudy of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness (Post-coma DBS)
Primary Purpose
Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Implantable neurostimulation system
Sponsored by
About this trial
This is an interventional treatment trial for Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State) focused on measuring Deep Brain Stimulation (DBS), Post-coma, Consciousness, Vegetative state, Minimally conscious state
Eligibility Criteria
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
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
deep brain stimulation
Arm Description
Outcomes
Primary Outcome Measures
CRS-R scores (Coma Recovery Scale-Revised)
Secondary Outcome Measures
signs of awakening at night
zerit burden interview
Full Information
NCT ID
NCT01718249
First Posted
October 29, 2012
Last Updated
November 22, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation de l'Avenir, Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT01718249
Brief Title
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
Acronym
Post-coma DBS
Official Title
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation de l'Avenir, Medtronic
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)
Keywords
Deep Brain Stimulation (DBS), Post-coma, Consciousness, Vegetative state, Minimally conscious state
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
deep brain stimulation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Implantable neurostimulation system
Primary Outcome Measure Information:
Title
CRS-R scores (Coma Recovery Scale-Revised)
Time Frame
after 2 months and after 7 months
Secondary Outcome Measure Information:
Title
signs of awakening at night
Time Frame
during the 10 months of the study
Title
zerit burden interview
Time Frame
at 1 month and at 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques LEMAIRE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
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