Frontosubthalamic Networks in Parkinson's Disease.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oxford
About this trial
The goal of this experimental study with is to understand the underlying mechanisms behind the increase in impulsivity seen in some patients that undergo deep brain stimulation of the subthalamic nucleus for Parkinson's Disease. The main questions it aims to answer are:
What are the distributed network effects of deep brain stimulation to the subthalamic nucleus? How does this correlate with increased impulsivity? Can alternative stimulation settings be used to minimize these?
Participants will complete decision-making tasks whilst their deep brain stimulation devices are turned on and off with simultaneous magnetoencephalography recordings (a type of non-invasive brain scan that measures brain activity in real-time)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the study.
Male or Female, aged 18 years or above.
Diagnosed with Parkinson's disease who have required implanted STN electrodes for DBS in addition to their dopamine replacement therapy.
Diagnosed with or without (control group) impulse control disorders since the diagnosis of Parkinson's Disease.
Disqualifiers
Patients with extreme language barrier that cannot understand the purpose or instructions of the study despite the use of an interpreter.
Other implanted medical devices that may cause artefacts during MEG recordings.
Participants with a history of co-morbid neurological disorders.
Participant enrolled onto another clinical trial related to a neurological disorder (including Parkinson's disease) that may interfere with the results of this study.
Trial design
Design model
Parallel
Treatments tested in this trial
DBS on/off
Other interventionDBS will be turned on and off for experimental periods to compare the effect of DBS on behaviour.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Parkinson's Disease DBS, no Impulse Control DisorderActive comparator 1 intervention
Group B: Parkinson's Disease DBS, with Impulse Control DisorderExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Identify effect of therapeutic STN-DBS on frontosubthalamic networks in PD related ICDs during decision making and impulse control
Correlation between response time and accuracy with electrophysiological signatures of neural activity.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov