Status:
TERMINATED
Intrathecal Baclofen Therapy and Paroxysmal Dysautonomia in Severe Brain-Injured Patients
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Traumatic Brain Injury
Cerebral Anoxia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Within the framework of a prospective double-blind and randomized study evaluating the efficacy of continuous intrathecal baclofen therapy (CIBT) on paroxysmal dysautonomia (main objective) and hypert...
Detailed Description
Background. Severe brain trauma and especially serious brain lesions inducing coma lead to many cases of disability. A large number of these patients (about 30%) present neurovegetative and hypertonic...
Eligibility Criteria
Inclusion
- severe brain injury with coma (Glasgow score \<8)
- Early phase of recovery (spontaneous eye-opening) since at least one month and less than six months
- severe hypertonia of the lower limbs (mean Ashworth score \>= 3) with neurovegetative episodes (at least 10 in 48 hours) and/or decortication after failure of treatment per os (clonidine, beta-blocker, baclofen per os)
- written informed consent (next of kin)
Exclusion
- surgical, anesthetic or allergic contraindication to baclofen
- uncontrolled sepsis directly threatening the implanted device
- associated medullary trauma
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00221689
Start Date
March 1 2003
End Date
February 1 2004
Last Update
June 13 2007
Active Locations (1)
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1
Service de neurochirurgie B, Hôpital Pellergin Tripode
Bordeaux, France, 33076