Evidence map›Paper›PMID 31050023›Full record

Trial reportAnnals of neurology2019

The Effect of Intrathecal Baclofen in Dyskinetic Cerebral Palsy: The IDYS Trial.

Laura A Bonouvrié, Jules G Becher, Johan S H Vles, R Jeroen Vermeulen, Annemieke I Buizer, IDYS Study Group

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06606574 (PREDICT-ITB), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06606574 narecruitingnot on this mapstarted 2024, after this paper: background citation

PREDICT-ITB: Predicting Response in Children With Dystonic Cerebral Palsy to Intrathecal Baclofen

TypeinterventionalSponsorBaylor College of MedicineRan2024 to 2029Enrolled65ConditionsDystonic Cerebral PalsyArmsTitration protocol
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Surgical treatment options for spasticity in children and adolescents with hereditary spastic paraplegia.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024
    Article
  12. Spasticity and movement disorders in cerebral palsy.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2023
    Review
  13. Intrathecal baclofen as an effective treatment for generalized dystonia in Wilson's disease.European journal of physical and rehabilitation medicine · 2023
    Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Neurobiological mechanisms associated with antipsychotic drug-induced dystonia.Journal of psychopharmacology (Oxford, England) · 2021
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Laura A BonouvriéAmsterdam University Medical Center, Free University Amsterdam, Department of Rehabilitation Medicine, Amsterdam Neuroscience, Amsterdam, the Netherlands.ORCID 0000-0002-7754-9830
Jules G BecherAmsterdam University Medical Center, Free University Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam, the Netherlands.
Johan S H VlesMaastricht University Medical Center, Department of Child Neurology, Maastricht, the Netherlands.
R Jeroen VermeulenMaastricht University Medical Center, Department of Child Neurology, Maastricht, the Netherlands.
Annemieke I BuizerAmsterdam University Medical Center, Free University Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam, the Netherlands.ORCID 0000-0001-5662-2843
IDYS Study Group
Amsterdam University Medical Centers · NLMaastricht University Medical Centre · NLAmsterdam Neuroscience · NL

Funding

Johanna KinderFonds 2011/0035-357Phelps Stichting voor Spastici 2011037Phelps Stichting voor Spastici 99.047Revalidatiefonds R2011032/Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting 11.02.17-2011/0035
6 · The paper itself

Abstract

objectiveIntrathecal baclofen treatment is used for the treatment of dystonia in patients with severe dyskinetic cerebral palsy; however, the current level of evidence for the effect is low. The primary aim of this study was to provide evidence for the effect of intrathecal baclofen treatment on individual goals in patients with severe dyskinetic cerebral palsy.

methodsThis multicenter, randomized, double-blind, placebo-controlled trial was performed at 2 university medical centers in the Netherlands. Patients with severe dyskinetic cerebral palsy (Gross Motor Functioning Classification System level IV-V) aged 4 to 24 years who were eligible for intrathecal baclofen were included. Patients were assigned by block randomization (2:2) for treatment with intrathecal baclofen or placebo for 3 months via an implanted microinfusion pump. The primary outcome was goal attainment scaling of individual treatment goals (GAS T score). A linear regression model was used for statistical analysis with study site as a covariate. Safety analyses were done for number and type of (serious) adverse events.

resultsThirty-six patients were recruited from January 1, 2013, to March 31, 2018. Data for final analysis were available for 17 patients in the intrathecal baclofen group and 16 in the placebo group. Mean (standard deviation) GAS T score at 3 months was 38.9 (13.2) for intrathecal baclofen and 21.0 (4.6) for placebo (regression coefficient = 17.8, 95% confidence interval = 10.4-25.0, p < 0.001). Number and types of (serious) adverse events were similar between groups.

interpretationIntrathecal baclofen treatment is superior to placebo in achieving treatment goals in patients with severe dyskinetic cerebral palsy. ANN NEUROL 2019.

Indexed as

AdolescentAdultBaclofenCerebral PalsyChildChild, PreschoolDouble-Blind MethodFemaleHumansInjections, SpinalMaleMuscle Relaxants, CentralTreatment OutcomeYoung AdultBaclofenMuscle Relaxants, Central

Identifiers

PMID31050023
PMCPMC6617761
OpenAlexW2942938096

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.