Alteration of Deep Brain Stimulation Parameters for Dystonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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60 Hz stimulation

Experimental reduced frequency pallidal stimulation

Group Type EXPERIMENTAL

Alteration of deep brain stimulator settings

Intervention Type PROCEDURE

From 130Hz to 60Hz pallidal stimulation

130 Hz stimulation

Current standard pallidal stimulation setting

Group Type NO_INTERVENTION

Alteration of deep brain stimulator settings

Intervention Type PROCEDURE

From 130Hz to 60Hz pallidal stimulation

Interventions

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Alteration of deep brain stimulator settings

From 130Hz to 60Hz pallidal stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primary dystonia (focal cervical or generalised dystonia) who are receiving chronic (\>1 year) bilateral pallidal stimulation but have had poor therapeutic responses (\< 50% improvement in relevant dystonia severity rating scale\*) despite confirmation of accurate electrode position.
* Able to understand study requirements - able to provide consent.

* Relevant dystonia rating scales: Cervical dystonia - severity subsection of the Toronto Western Hospital spasmodic torticollis rating scale; Generalised dystonia - severity section of the Burke Fahn Marsden rating scale.