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NCT Number: NCT06485986

Frontosubthalamic Networks in Parkinson's Disease.

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Radcliffe Hospital

Oxford, OX39DU, United Kingdom

Location status: Recruiting

Location contact

John Eraifej, BSc MBChB MRCS

CONTACT

01865222763

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBS on/off

Other

DBS will be turned on and off for experimental periods to compare the effect of DBS on behaviour.

Primary outcomes

  1. Identify effect of therapeutic STN-DBS on frontosubthalamic networks in PD related ICDs during decision making and impulse control

    Time frame: 12 months

    Correlation between response time and accuracy with electrophysiological signatures of neural activity.

Study contacts

Contact information is provided by the study sponsor or research team.

John Eraifej, BSc MBChB MRCS

CONTACT

[email protected]

01865222763

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Frontosubthalamic Network Dynamics and Their Modulation During Impulse Control and Decision Making in Parkinson's Disease

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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