There are limited therapeutical options for patients with secondary dystonia due to cerebral palsy. Pharmacotherapy is often without effect, or side effects are severe. Meanwhile deep brain stimulation (DBS) has proven to be a safe and effective therapy for patients with parkinson´s disease or primary / idiopathic dystonia. Experiences with DBS in patients with dyskinetic cerebral palsy are limited with heterogeneous data. With STIM-CP we investigate the effect of DBS on quality of life in young patients with a dyskinetic movement disorder (dyskinetic cerebral palsy) due to perinatal hypoxic brain injury. Additionally, the effect of DBS on motor development, speech, memory, attention, cognition and pain perception will be assessed.
In total, 20 patients aged 7-18 years diagnosed with dyskinetic cerebral palsy due to perinatal asphyxia, who will receive DBS, should be included. 11 German DBS-centres will participate in the trial. Effects of DBS will be assessed up to 36 months after Initial Implantation. There are two preoperative visits (screening and baseline) and nine postoperative visits (implantation, 3-, 6-, 9-, 12-, 24- and 36-moths follow-up). We assume that DBS reduces the severity of dystonia and improves the quality of life in these patients.
Study Type
OBSERVATIONAL
Enrollment
16
University Hospital Cologne
Cologne, Northern Westfalia, Germany
Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD)
Difference in CPCHILD before and 36 months on DBS (response=improvement \> 10%)
Time frame: CPCHILD 12 months after DBS
Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability
Assessment of the severity of dystonia
Time frame: 0, 6, 12, 24 and 36 months after DBS
Dyskinesia Impairment Scale
Assessment of the severity of chorea and dystonia
Time frame: 0, 12, 24 and 36 months
Tardieu Scale
Assessment of the severity of spasticity
Time frame: 0 and 12 months after DBS
Frenchay Dysarthria Assessment
Assessment of speech and swallowing
Time frame: 0, 12, 24 and 36 months after DBS
SF-36
Assessment of Quality of life
Time frame: 0, 6, 12, 24 and 36 months after DBS
Strengths and Difficulties Questionnaire
Assessment of mood and attention
Time frame: 0, 6, 12, 24 and 36 months after DBS
Snijders-Oomen-Non-Verbal-Intelligence Test (SON-R)
Assessment of Cognition
Time frame: 0 and 12 months
Attentional Network Test (ANT)
Assessment of Attention
Time frame: 0 and 12 months after DBS
Non-Verbal-Learning Test (NVLT)
Assessment of cognition
Time frame: 0 and 12 months after DBS
Wong Baker Faces
Assessment of pain
Time frame: 0, 6, 12, 24 and 36 months after DBS
Family Scale (FaBel)
Assessment of the burden for caregivers
Time frame: 0, 6, 12, 24 and 36 months after DBS
Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD)
Assessment of quality of life
Time frame: 0, 6, 24 and 36 months after DBS
Canadian Occupational Performance Measure (COPM)
Assessment of activities of daily living
Time frame: COPM 0 and 12 months after DBS
Gross Motor Function Measure (GMFM-66)
Assessment of physical disability
Time frame: GMFM-66 0 and 12 months after DBS
Gross Motor Function Classification System (GMFCS)
Degree of physical impairment
Time frame: GMFCS 0, 12, 24 and 36 months after DBS
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