gms | German Medical Science

56. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e. V. (DGNC)
3èmes journées françaises de Neurochirurgie (SFNC)

Deutsche Gesellschaft für Neurochirurgie e. V.
Société Française de Neurochirurgie

07. bis 11.05.2005, Strasbourg

Continuous Intrathecal Baclofen Infusion for spastic cerebral palsy: a prospective multicenter study

Meeting Abstract

  • corresponding author Y. Lazorthes - Dept. of Neurosurgery, Hôpital Rangueil-Larrey, Toulouse
  • M. Sindou - Dept. of Neurosurgery, Hôpital Neurologique Pierre Wertheimer, Lyon
  • S. Blond - Dept. of Neurosurgery, Hôpital Roger Salengro, Lille
  • R. Cavagna - Dept. of Orthopaedic Surgery, Clinique du Ter, Ploemeur
  • B. Scherpereel - Dept. of Neurosurgery, Hôpital Maison Blanche, Reims
  • J. Godard - Dept. of Neurosurgery, Hôpital Jean Minjoz, Besançon
  • D. Orenstein - Dept. of Neurosurgery, Clinique du Diaconat, Mulhouse
  • P. Paquis - Dept. of Neurosurgery, Hôpital Pasteur, Nice
  • S. Gangloff - Dept. of Orthopaedic Surgery, Clinique Ste Jeanne d'Arc, Saint-Brieuc
  • R. Duthel - Dept. of Neurosurgery, Hôpital Bellevue, Saint-Etienne
  • B. Irthum - Dept. of Neurosurgery, Hôpital Gabriel Montpied, Clermont-Ferrand

Deutsche Gesellschaft für Neurochirurgie. Société Française de Neurochirurgie. 56. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC), 3èmes journées françaises de Neurochirurgie (SFNC). Strasbourg, 07.-11.05.2005. Düsseldorf, Köln: German Medical Science; 2005. Doc10.05.-01.03

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dgnc2005/05dgnc0098.shtml

Veröffentlicht: 4. Mai 2005

© 2005 Lazorthes et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Objective

This prospective multicentric study (n=11 centers) was designed to determine if Continuous Intrathecal Baclofen Infusion (CIBI) would provide significant benefit for children with spastic cerebral palsy. The goal of treatment is not only the relief of spasticity, but the ultimate improvement of motor and functional performance. The protocol was submitted to the Ethical Committee of the Toulouse University Hospital (CCPPRB), and approved in October 1999.

Methods

24 patients were selected over a 2-year period, according to rigourous criteria and a multidisciplinary clinical approach (age between 6 and 18 years, severe diffuse spasticity with a mean Ashworth score ≥3 at the lower limbs, failure of well-conducted oral baclofen treatment due to side effects, surgical feasability of pump implant, and signed informed consent). All patients underwent a double-blind placebo-controlled trial screening with intrathecal bolus administration of baclofen doses (initial dose of 12.5 or 25 μg, progressively increased up to a maximum dose of 100 μg) until efficacy criteria were met (reduction of a least 1-level in mean Ashworth lower limb score). 19 patients were finally considered for the implantation of a programmable pump (SynchroMed® system with a 10cc reservoir).

Assessment included spasticity scoring (Ashworth scale) of lower and upper limbs, quantitative functional evaluation (Gross Motor Function Measure Scale), and a qualitative questionnaire designed to evaluate the subjective perception of global daily life results of CIBI treatment by the patient, his family, and the physician.bs

Results

Out of the 24 screened patients, 5 were not implanted due to complications (CSF leaks, spinal headaches …) despite a good clinical benefit on spasticity. Spasticity double-blind, placebo-controlled evaluation resulted in the reduction of the mean Ashworth score of the lower limbs from 3.7 (initial evaluation) to 1.8 with a mean baclofen dose of 44 μg and to 3.5 with the placebo administration.

Follow-up evaluations at 24 months after pump implant showed a stable significant effect on lower limbs spasticity scores (mean: 2.4) as on upper limbs scores (mean: 1.9) as average daily dose raised to 186 μg between 6 and 24 months following implant. Though medical staffs reported functional improvements in some patients (locomotion), GMFM average scores remained stable all through the study. Qualitative questionnaires indicated that patients, families and medical staff were satisfied with global outcome (ease of mobilisation, reduction of pain, sleep improvement). Complications occurred in 10 patients, mostly in the first months of therapy and were not followed by any pump explant.

Conclusions

This studies confirms that CIBI significantly reduces severe spasticity in children with cerebral palsy with a clear benefit on patients comfort and care.