Studying Movement Control in Parkinson's Disease Using Closed Loop Deep Brain Stimulation
NCT02585154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2021-05-04
Summary
Parkinson's disease is a common, disabling, progressive condition characterised by severe problems with movement for which medical treatment in the longer term can be unsatisfactory. Deep brain stimulation is a treatment, which directly stimulates the nerve cells affected inside the brain to help overcome the difficulties with movement. Classically, deep brain stimulation stimulates in a manner that is constant and independent of a patients underlying condition as reflected in their brainwave activity. Recent research has suggested that adjusting deep brain stimulation in real time using analyses of brain signals recorded from deep brain stimulation electrodes (termed closed loop deep brain stimulation) nay be better than classical deep brain stimulation in alleviating difficulties with movement. However, it remains unclear whether closed-loop deep brain stimulation also leads to fewer unwanted side effects on movement control. In order to answer this question, the investigators will analyze deep brain stimulation activity and activity recorded from the surface of the head in Parkinson's disease patients undergoing deep brain stimulation surgery. During the recordings patients will perform different movement tasks. Deep brain stimulation has been found to reduce patients' ability to suppress inappropriate movements in certain tasks and performance in these tasks will be the core point of interest. The recordings will be conducted three times: During closed loop deep brain stimulation, classical deep brain stimulation and while the stimulator is turned off. This will allow the investigators to assess putative differences in the effect of closed loop and classical deep brain stimulation with regards to wanted and unwanted effects on movement control and to elucidate their correlates in the brain.
Conditions
- Parkinson Disease
Interventions
- PROCEDURE
-
Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015)
'Classical' high-frequency Deep Brain Stimulation, which is applied irrespective of ongoing brain activity.
- PROCEDURE
-
closed-loop Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015)
Deep Brain Stimulation, which is applied depending on ongoing brain activity.
- PROCEDURE
-
Deep Brain Stimulation off
Deep Brain Stimulation is turned off.
- DEVICE
-
local field potentials and electroencephalography recordings
Simultaneous recordings of local field potentials from subthalamic nucleus and electroencephalography
Sponsors & Collaborators
-
University of Oxford
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-08
- Primary Completion
- 2017-07-01
- Completion
- 2019-12-31
Countries
- United Kingdom
Study Locations
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