None listed
Conditions
Brief summary
Cerebral Palsy (CP) is a neurodevelopmental disorder secondary to injury of the fetal or infant brain causing dystonia, choreoathetosis, and / or spasticity. Deep Brain Stimulation (DBS) improves motor function and quality of life in other forms of dystonia. There are case reports suggesting that DBS improves motor function in dystonic CP as well. This is a proposal to investigate the impact of DBS on motor function and quality of life in adolescents and adults with CP in a randomized, blinded, placebo-controlled design.
Interventions
All patients will have deep brain stimulator implanted in the globus pallidus internus, which is part of the basal ganglia network in the brain. The implantation of deep brain stimulators takes approximately 3 to 6 hours. Deep brain stimulators are similar to cardiac pacemakers and the battery is placed - like in pacemakers - under the collar bone. However the electrodes are not in the heart but end in the brain where they stimulate certain areas of the brain - in our study the pallidum or globu
All patients will have deep brain stimulator implanted in the globus pallidus internus, which is part of the basal ganglia network in the brain. The implantation of deep brain stimulators takes approximately 3 to 6 hours. Deep brain stimulators are similar to cardiac pacemakers and the battery is placed - like in pacemakers - under the collar bone. However the electrodes are not in the heart but end in the brain where they stimulate certain areas of the brain - in our study the pallidum or globus pallidus internus. This part of the brain is involved in involuntary movements. We believe that continuous high frequency stimulation of this part of the brain can block involuntary movements and improve dystonia. The treatment group will receive effective continuous stimulation through their implanted deep brain stimulators for three months; The standard setting of the stimulator are pulse width of 90µs, 130 Hz and the highest possible amplitude , that does not cause side effects. The sham group will receive ineffective stimulation through their implanted deep brain stimulators which will mean the stimulator is switched on with the same settings but amplitude of 0 Volt.
Sponsors
Martin Krause
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
10 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Dystonic or dyskinetic Cerebral Palsy
Exclusion criteria
Dementia Predominant Spasticity
Outcome results
None listed