Study Results
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Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2018-05-02
2018-10-24
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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30us stimulation then 60us stimulation
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.
Deep brain stimulation
The different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer.
60us stimulation then 30us stimulation
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.
Deep brain stimulation
The different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer.
Interventions
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Deep brain stimulation
The different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer.
Eligibility Criteria
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Inclusion Criteria
* Treatment with subthalamic deep brain stimulation using Medtronic Activa PC hardware for at least 12 months.
* Experiencing stimulation-induced slurring of speech defined as scoring 50-80% speech intelligibility on the Assessment of Intelligibility of Speech scale.
* All patients will be ≥ 25 and ≤ 75 years of age.
* Documented informed consent to participate.
Exclusion Criteria
* Already actively participating in an investigation of a drug, device or surgical treatment for Parkinson's disease.
* Potential participants who lack the capacity to give informed consent.
* Any medical, psychiatric or other condition which in the investigator's opinion compromises the potential participant's ability to participate fully.
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Thomas Foltynie, MRCP PhD
Role: PRINCIPAL_INVESTIGATOR
UCL Institute of Neurology
Locations
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UCL Institute of Neurology
London, , United Kingdom
Countries
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Other Identifiers
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16/0772
Identifier Type: -
Identifier Source: org_study_id
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