Alteration of Deep Brain Stimulation Parameters for Dystonia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dystonia |
Procedure: Alteration of deep brain stimulator settings |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Alteration of Deep Brain Stimulation Parameters for Dystonia- A Double Blinded Randomised Controlled Trial |
- 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 ] [ Designated as safety issue: No ]
- Assess any potential changes in anxiety, mood, cognition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 60 Hz stimulation
Experimental reduced frequency pallidal stimulation
|
Procedure: Alteration of deep brain stimulator settings
From 130Hz to 60Hz pallidal stimulation
|
|
No Intervention: 130 Hz stimulation
Current standard pallidal stimulation setting
|
Procedure: Alteration of deep brain stimulator settings
From 130Hz to 60Hz pallidal stimulation
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Exclusion Criteria:
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00971854
| Contact: Wesley Thevathasan, MBBS FRACP | 07748729186 | wesley.thevathasan@nds.ox.ac.uk | |
| Contact: Julian Woollard, MMBS BSc | 07779 654 944 | julian.woollard@doctors.org.uk |
| United Kingdom | |
| University of Oxford, Nuffield Department of Surgery | Recruiting |
| Oxford, Oxfordshire, United Kingdom, OX3 9DU | |
| Contact: Wesley Thevathasan, MBBS FRACP 07748729186 wesley.thevathasan@nds.ox.ac.uk | |
| Contact: Julian Woollard, MBBS BSc 07779 654 944 julian.woollard@doctors.org.uk | |
| Sub-Investigator: Carole Joint | |
| Sub-Investigator: Beth Furrow | |
| Sub-Investigator: Julian Woollard | |
| Principal Investigator: | Tipu Aziz, Professor | University of Oxford, Nuffield Department of Surgery |
More Information
| Responsible Party: | Heather House, University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00971854 History of Changes |
| Other Study ID Numbers: | 09/H0603/11 R&D Study - 5898 |
| Study First Received: | September 3, 2009 |
| Last Updated: | October 12, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Oxford:
|
Dystonia |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Dyskinesias Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016