Overview

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