Frontosubthalamic Networks in Parkinson's Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DBS on/off.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Impulse Control Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Frontosubthalamic Network Dynamics and Their Modulation During Impulse Control and Decision Making in Parkinson's Disease
Overview
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)
Interventions
- Other DBS on/off
DBS will be turned on and off for experimental periods to compare the effect of DBS on behaviour.
Primary outcome measures
- Identify effect of therapeutic STN-DBS on frontosubthalamic networks in PD related ICDs during decision making and impulse control [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
- Participant willing and able to sit in the MEG scanner and follow instructions.
- Participant willing and able to delay their morning dose of dopamine replacement therapy for up to four hours (180 minutes experimental time + journey time).
Exclusion criteria
- 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.
- Participants who are unable to sit still in a MEG scanner for the duration of this experiment e.g. patients with chronic pain or osteoarthritis. This will be assessed with their primary clinician
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United Kingdom · 1 center
- John Radcliffe Hospital — Oxford
Publications
- Herz DM, Frank MJ, Tan H, Groppa S. Subthalamic control of impulsive actions: insights from deep brain stimulation in Parkinson's disease. Brain. 2024 Nov 4;147(11):3651-3664. doi: 10.1093/brain/awae184. PMID 38869168
- Eraifej J, Cabral J, Fernandes HM, Kahan J, He S, Mancini L, Thornton J, White M, Yousry T, Zrinzo L, Akram H, Limousin P, Foltynie T, Aziz TZ, Deco G, Kringelbach M, Green AL. Modulation of limbic resting-state networks by subthalamic nucleus deep brain stimulation. Netw Neurosci. 2023 Jun 30;7(2):478-495. doi: 10.1162/netn_a_00297. eCollection 2023. PMID 37397890
Identifiers
NCT: NCT06485986 · PID14888