No registrations found.
ID
Source
Brief title
Health condition
dystonia, dyskinesia, dystonic cerebral palsy, dyskinetc cerebral palsy, cerebral palsy, intrathecal baclofen, ITB
Sponsors and support
Maastricht University Medical Center
Johanna KinderFonds
Kinderrevalidatiefonds de Adriaanstichting
RevalidatieFonds
Intervention
Outcome measures
Primary outcome
Goal Attainment Scaling.
Secondary outcome
1. 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.
Background summary
Treatment 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.
Study objective
1. 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.
Study design
1. Baseline;
2. 3 months;
3. 1 year.
Intervention
Blinded 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).
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3510 |
| NTR-old | NTR3642 |
| CCMO | NL33312.029.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON45097 |