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…
ID
Bron
Verkorte titel
Aandoening
dystonia, dyskinesia, dystonic cerebral palsy, dyskinetc cerebral palsy, cerebral palsy, intrathecal baclofen, ITB
Ondersteuning
Maastricht University Medical Center
Johanna KinderFonds
Kinderrevalidatiefonds de Adriaanstichting
RevalidatieFonds
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Goal Attainment Scaling.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1. Baseline;
2. 3 months;
3. 1 year.
Onderzoeksproduct en/of interventie
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).
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3510 |
| NTR-old | NTR3642 |
| CCMO | NL33312.029.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON45097 |