Status:
COMPLETED
Short Pulse Width DBS in Parkinson's Disease
Lead Sponsor:
University College, London
Conditions:
Parkinson's Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 su...
Detailed Description
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) DB...
Eligibility Criteria
Inclusion
- Diagnosis of Parkinson's disease - PD is a clinical diagnosis and is based on the opinion of the PI on site after review of the clinical history, examination findings and response to PD medication. The Queen Square brain bank criteria MAY be used to help assist in the diagnosis although this need not be a formal inclusion criteria, and the relevance of a positive family history of PD, or a confirmed genetic basis for an individual's symptoms will be evaluated in the context of other clinical features in determining diagnosis and eligibility.
- Male or Female.
- 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
- Patients unable to provide documented informed consent.
- 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.
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03417271
Start Date
May 2 2018
End Date
October 24 2018
Last Update
April 17 2019
Active Locations (1)
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1
UCL Institute of Neurology
London, United Kingdom, WC1N 3BG