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

NCT00221689 | Terminated Phase 2 DMC

• 2 other identifiers: 9244-012001-009
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Cerebral Anoxia; Coma; Hypertonia; Dysautonomia

Keywords

Severe brain injury; Coma; Hypertonia; Dysautonomia; Baclofen; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• Number of neurovegetative episodes

  day 6 and day 7

Secondary Outcomes (3)

• Ashworth scale

• Whim scale

• Adverse events

Interventions

baclofen (drug) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• surgical, anesthetic or allergic contraindication to baclofen
• uncontrolled sepsis directly threatening the implanted device
• associated medullary trauma

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Service de neurochirurgie B, Hôpital Pellergin Tripode

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hypoxia, Brain; Coma; Muscle Hypertonia; Autonomic Nervous System Diseases; Brain Injuries

Interventions

Baclofen; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Emmanuel Cuny, Professor

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Paul Perez, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2003
• Study Completion: February 1, 2004
• Last Updated: June 13, 2007

Record last verified: 2007-06

Locations

FR (1)