Clinical Trial: Alteration of Deep Brain Stimulation Parameters for Dystonia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Alteration of Deep Brain Stimulation Parameters for Dystonia- A Double Blinded Randomised Controlled Trial
Brief Summary:
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 dyst
Detailed Summary:
Sponsor: University of Oxford
Current Primary Outcome: To assess if the stimulation frequency of 60 Hz is superior to 130 Hz for patients with primary dystonia who have responded poorly to standard 130 Hz pallidal stimulation [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Assess any potential changes in anxiety, mood, cognition [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: University of Oxford
Dates:
Date Received: September 3, 2009
Date Started: September 2009
Date Completion: February 2010
Last Updated: October 12, 2009
Last Verified: September 2009
