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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718249
First Posted: October 31, 2012
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fondation de l'Avenir
Medtronic
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose
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.

Condition Intervention
Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State) Other: Implantable neurostimulation system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • CRS-R scores (Coma Recovery Scale-Revised) [ Time Frame: after 2 months and after 7 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Actual Study Start Date: April 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
deep brain stimulation Other: Implantable neurostimulation system

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718249


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fondation de l'Avenir
Medtronic
Investigators
Principal Investigator: Jean-Jacques LEMAIRE University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01718249     History of Changes
Other Study ID Numbers: CHU-0126
2011-A00300-41
First Submitted: October 29, 2012
First Posted: October 31, 2012
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by University Hospital, Clermont-Ferrand:
Deep Brain Stimulation (DBS)
Post-coma
Consciousness
Vegetative state
Minimally conscious state

Additional relevant MeSH terms:
Disease
Coma
Consciousness Disorders
Persistent Vegetative State
Pathologic Processes
Unconsciousness
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases