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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
Fondation de l'Avenir
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand Identifier:
First received: October 29, 2012
Last updated: October 11, 2013
Last verified: October 2013
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 Blind (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 ]

Estimated Enrollment: 4
Study Start Date: April 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01718249

Contact: Patrick LACARIN 04 73 75 11 95

CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fondation de l'Avenir
Principal Investigator: Jean-Jacques LEMAIRE University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01718249     History of Changes
Other Study ID Numbers: CHU-0126
Study First Received: October 29, 2012
Last Updated: October 11, 2013

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

Additional relevant MeSH terms:
Consciousness Disorders
Persistent Vegetative State
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Unconsciousness processed this record on May 25, 2017