Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness (Post-coma DBS)
This study is currently recruiting participants.
Verified October 2012 by University Hospital, Clermont-Ferrand
Sponsor:
University Hospital, Clermont-Ferrand
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 30, 2012
Last verified: October 2012
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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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718249
Contacts
| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
Locations
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fondation de l'Avenir
Medtronic
Investigators
| Principal Investigator: | Jean-Jacques LEMAIRE | University Hospital, Clermont-Ferrand |
More Information
Additional Information:
No publications provided
| 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 30, 2012 |
| 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:
|
Coma Cogan Syndrome Consciousness Disorders Persistent Vegetative State Unconsciousness Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Vestibulocochlear Nerve Diseases |
Cranial Nerve Diseases Eye Diseases Vasculitis Vascular Diseases Cardiovascular Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013