Dystonia Clinical Trial
Official title:
Alteration of Deep Brain Stimulation Parameters for Dystonia- A Double Blinded Randomised Controlled Trial
Deep brain stimulation (DBS) involves placing electrodes into the brain. Through these
electrodes, artificial electrical signals are chronically delivered into deep brain regions
in order to alter abnormal brain activity. The artificial electrical signals are generated
by a battery that is inserted under the skin of the chest. DBS is used to treat several
disorders of movement, including dystonia. In dystonia, the electrodes are inserted into a
brain region called the globus pallidus.
Globus pallidus stimulation can be very effective therapy for dystonia. However not all
patients are equally responsive and therapeutic outcomes can be frustratingly variable. The
reason for this variability is unclear. Such variability in response may need to be met by
tailoring stimulation to individual patients.
Another issue with deep brain stimulation is battery life. Eventually, batteries become
depleted and need to be replaced. Such battery replacements require an operation, hospital
stay and the risk of introducing infection. The high electrical energy that has been used to
treat dystonia means that batteries are typically replaced every year or two.
The artificial electrical signals of deep brain stimulation are delivered with three
parameters; frequency (Hertz - Hz), voltage (volts) and pulse width (microseconds). It has
recently been reported that lower frequency stimulation, at 60Hz rather than 130Hz, can be
used effectively to treat dystonia. Such 60Hz stimulation may be more effective for some
patients than others. The lower energy demands of 60Hz stimulation would also greatly
improve battery life (potentially doubling battery life).
The aim of this study is to assess if 60Hz stimulation is more effective in ameliorating the
dystonia of patients who have responded poorly to 130Hz pallidal stimulation. The current
status of the evidence is one of clinical equipoise (uncertainty) and therefore suits a
double blinded randomised trial.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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