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Intrathecal baclofen treatment in dystonic cerebral palsy: A randomized clinical trial.


- candidate number13386
- NTR NumberNTR3642
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2012
- Secondary IDsNL33312.029.10 CCMO
- Public TitleIntrathecal baclofen treatment in dystonic cerebral palsy: A randomized clinical trial.
- Scientific TitleIntrathecal baclofen treatment in dystonic cerebral palsy: A randomized clinical trial.
- ACRONYMIDYS trial
- hypothesis1. Intrathecal baclofen treatment in patients with dystonic cerebral palsy will improve daily activities and daily care, dystonia and spasticity;
2. Intrathecal baclofen treatment has no effect on independent functioning;
3. Patient characteristics such as location and severity of MRI lesions and Gross Motor Functioning Classification System (GMFCS) level might influence the effect of Intrathecal baclofen treatment in patients with dystonic cerebral palsy.
- Healt Condition(s) or Problem(s) studiedDystonia, Cerebral palsy, Baclofen, Dyskinesia
- Inclusion criteria1. Dystonic cerebral palsy;
2. Gross Motor Functioning Classification System (GMFCS) level IV or V;
3. Eligible for Intrathecal baclofen treatment using criteria of common practice;
4. Lesions on MRI (cerebral white matter, basal ganglia, central cortex);
5. Aged 4 to 25 years old;
6. Able and willing to complete study protocol;
7. Consensus about inclusion.
- Exclusion criteria1. Contra-indications for general anesthesia;
2. Contra-indications for baclofen;
3. Oral pharmacological treatment is sufficient;
4. Inadequate knowledge of Dutch or english language (parent and/or patient);
5. Deep brain stimulation;
6. Ventriculoperitoneal drain;
7. Other disorders interfering with treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-nov-2012
- planned closingdate30-apr-2015
- Target number of participants30
- InterventionsBlinded treatment with ITB or placebo via an implanted micro-infusion pump (3 months). Followed by a 9 month follow up in which all patients receive ITB (unblinded).
- Primary outcomeGoal Attainment Scaling.
- Secondary outcome1. Pediatric Evaluation of Disability Inventory;
2. Barry Albright Dystonia Scale;
3. Dyskinesia Impairment Scale;
4. Electromyography;
5. H-reflex;
6. Visual Analogue Scale for pain and comfort.
- Timepoints1. Baseline;
2. 3 months;
3. 1 year.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.J. Vermeulen
- CONTACT for SCIENTIFIC QUERIES R.J. Vermeulen
- Sponsor/Initiator VU University Medical Center, Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Phelps Stichting, Johanna Kinderfonds, Revalidatiefonds, Kinderrevalidatiefonds de Adriaanstichting
- PublicationsN/A
- Brief summaryTreatment optios for severe dystonic cerebral palsy is limited. Intrathecal baclofen treatment is used but the effects on the level of activities and participation remain unclear. Furthermore it is not know which patients benifit and which patients do not. With this multicenter, randomised controlled trial we aim to answer these questions.
- Main changes (audit trail)
- RECORD30-sep-2012 - 18-okt-2012


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