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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
Sponsor:
Collaborators:
Fondation de l'Avenir
Medtronic
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01718249
First received: October 29, 2012
Last updated: October 11, 2013
Last verified: October 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • signs of awakening at night [ Time Frame: during the 10 months of the study ] [ Designated as safety issue: Yes ]
  • zerit burden interview [ Time Frame: at 1 month and at 10 months ] [ Designated as safety issue: Yes ]

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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 
Study First Received: October 29, 2012
Last Updated: October 11, 2013
Health Authority: France: Ministry of Health

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
Persistent Vegetative State
Consciousness Disorders
Pathologic Processes
Unconsciousness
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016