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

June 12, 2007 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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 three weeks. Waking will be assessed by the WHIM scale on D5 each week. Adverse events are assessed throughout the 3 weeks of study.

Eligibility criteria. Inclusion criteria are focal or diffuse encephalic lesions leading to coma (Glasgow score <8), age 18 years or over, in waking phase (spontaneous eye-opening) since at least one month and less than six months, severe hypertonia of the lower members (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). Non inclusion criteria are surgical, anesthetic or allergic contraindication to baclofen, uncontrolled sepsis directly threatening the implanted device or associated medullary trauma.

Expected results. Throughout the trial the patients will be hospitalized in the neurosurgical or neurological intensive care departments. Expected results are a very clear decrease in the number of neurovegetative episodes and a substantial reduction in hypertonia, at least in the lower limbs. It will also be possible to quantify the consequences of these improvements on waking.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Service de neurochirurgie B, Hôpital Pellergin Tripode

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of neurovegetative episodes
Time Frame: day 6 and day 7
day 6 and day 7

Secondary Outcome Measures

Outcome Measure
Adverse events
Ashworth scale
Whim scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Emmanuel Cuny, Professor, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

June 13, 2007

Last Update Submitted That Met QC Criteria

June 12, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9244-01
  • 2001-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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