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The aim of this investigation is to explore the effect of reducing conventional pulse width of stimulation on known adverse effects of Subthalamic nucleus Deep Brain Stimulation (STN DBS) treatment such as; slurring of speech, gait impairment, and unsteadiness. This investigation is designed such that each of 16 patients (who have all had chronically implanted DBS systems), will be assessed using conventional (DBS-60µs) and short (DBS-30µs) pulse width DBS, in a randomised order.
Conventional DBS most commonly uses 60µs pulse width stimulation. Higher pulse widths are less well tolerated by patients as a result of adverse effects. The ability to use short pulse width (30µs) DBS in chronically implanted STN-DBS patients has been made possible as a result of the provision of a novel software flashcard (8870 XBP application card) developed by Medtronic, compatible with the routine Medtronic N'Vision 8870 Clinician Programmer. The Medtronic 8870-XBP flashcard will enable shorter pulse width (30µs) to be used with previously implanted conventional Medtronic DBS hardware, however this is not licensed at present.
The aim of this clinical investigation is to confirm the longevity of response and the clinical relevance of DBS-30µs versus DBS-60µs in DBS patients using "optimized" stimulation amplitudes for each pulse-width. This project will be conducted in patients with Parkinson's disease who have had long term bilateral sub thalamic nucleus Deep Brain Stimulation implants. As such, they will be regular attenders at the Unit of Functional Neurosurgery, National Hospital for Neurology & Neurosurgery, and will have had frequent previous attempts at adjusting their DBS parameters including overnight stays, and off- medication assessments to optimize motor function and minimize adverse effects. They will be familiar with all procedures to be used in this study. They will be aware that the objective of the study is to identify whether additional improvements in dysarthric speech can be achieved by the use of a short pulse width setting and therefore will be highly motivated to participate.
This investigation is designed such that each patient will be assessed under the DBS-30µs and DBS-60µs pulse width condition, in a randomised order. The patients and rating clinicians will be blinded to randomisation order. An unblinded clinician will be responsible for programming the stimulation. The use of a crossover design allows each patient to essentially act as their own control subject, and will maximise the ability to judge using paired statistical tests whether there is a consistent advantage in speech intelligibility using the shorter pulse width (DBS-30µs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30us stimulation then 60us stimulation | Active Comparator | All patients will receive both types of stimulation in a randomised crossover design. This arm will receive 30us stimulation for 4 weeks then will be switched to 60us stimulation for 4 weeks. |
|
| 60us stimulation then 30us stimulation | Active Comparator | All patients will receive both types of stimulation in a randomised crossover design.This arm will receive 60us stimulation for 4 weeks then will be switched to 30us stimulation for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | The different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility test | Percentage of intelligible words spoken during formal speech assessment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorders Society Unified Parkinson's Disease Rating Scale | Validated movement scale for Parkinson's disease. Range 0-132. Higher scores indicate worse disability. | 4 weeks |
| Dyskinesia Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Foltynie, MRCP PhD | UCL Institute of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL Institute of Neurology | London | WC1N 3BG | United Kingdom |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Neither participants nor outcomes assessors will be aware whether the patient is receiving stimulation at 30us or 60us pulse widths.
Validated dyskinesia rating scale. Range 0-104. Higher scores indicate worse disability.
| 4 weeks |
| Verbal Fluency | Number of words produced in 1 minute | 4 weeks |
| Timed Motor tests | Walking and hand tapping | 4 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |