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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Early Treatment of Paroxysmal Dysautonomia and Hypertonia for Severe Brain Injured Patients by Intrathecal Baclofen Therapy

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 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.

Detailed Summary:

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 episodes that are associated to a bad vital prognosis and the degree of disability. Several teams including two in France have reported the efficacy of intrathecal baclofen on such neurovegetative episodes that to date have not been able to be treated efficiently.

Objectives. The main objective of this trial is to assess the efficacy of infused intrathecal baclofen on the number of neurovegetative episodes in seriously brain-injured patients. The secondary aims are to evaluate the efficacy of the treatment on hypertonia, to assess changes in waking and treatment safety.

Study design. Double-blind randomized trial on two parallel groups. The second part of the study is open label: both groups receive the experimental treatment.

Intervention

Experimental group: continuous progressive dose of intrathecal baclofen for one week; constant dose of baclofen during the second week receives at a dose determined after the first week. Treatment is stopped after two weeks, but patients are assessed until the end of the third week.

Control group: intrathecal placebo for one week; progressive dose of intrathecal baclofen during the second week. Treatment is stopped after two weeks, but patients are assessed until the end of the third week.

Outcomes. The main outcome is the number of neurovegetative episodes in the last 48 hours of the first week of treatment. Secondary outcomes are hypertonia as measured by the Ashworth scale on D2 to D5 of all
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Number of neurovegetative episodes [ Time Frame: day 6 and day 7 ]

Original Primary Outcome: Number of neurovegetative episodes at D6 and D7

Current Secondary Outcome:

  • Ashworth scale
  • Whim scale
  • Adverse events


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: September 13, 2005
Date Started: March 2003
Date Completion:
Last Updated: June 12, 2007
Last Verified: June 2007