Intrathecal Baclofen Therapy and Paroxysmal Dysautonomia in Severe Brain-Injured Patients

• Status: Terminated
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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 hypertonia, recovery and tolerance (secondary objectives) during the initial recovery phase of severe head injury, continuous intrathecal baclofen infusion will be delivered. The first week of study is double-blind: the first of two parallel groups receives CIBT and the second group receives placebo. The main outcome (number of neurovegetative episodes) is assessed at the end of first week. The second week of study is open labeled: active treatment is continued in the first group and the second group starts active CIBT treatment. The third week of study, treatment is stopped in both groups.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Ministry of Health, France
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• surgical, anesthetic or allergic contraindication to baclofen

• uncontrolled sepsis directly threatening the implanted device

• associated medullary trauma