Frontosubthalamic Networks in Parkinson's Disease.

March 27, 2025 updated by: University of Oxford

Frontosubthalamic Network Dynamics and Their Modulation During Impulse Control and Decision Making 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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX39DU
        • Recruiting
        • John Radcliffe Hospital
        • Contact:
          • John Eraifej, BSc MBChB MRCS
          • Phone Number: 01865222763

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parkinson's Disease DBS, no Impulse Control Disorder
Patients with Parkinson's disease who are treated with deep brain stimulation (DBS) but have not developed impulsive or compulsive behaviours will undertake a computerised task with their DBS turned on and off with simultaneous magnetoencephalography. After each experiment, normal therapy will be resumed.
Other: DBS on/off
DBS will be turned on and off for experimental periods to compare the effect of DBS on behaviour.
Experimental: Parkinson's Disease DBS, with Impulse Control Disorder
Patients with Parkinson's disease who are treated with deep brain stimulation (DBS) who have developed impulsive or compulsive behaviours will undertake a computerised task with their DBS turned on and off with simultaneous magnetoencephalography. After each experiment, normal therapy will be resumed.
Other: DBS on/off
DBS will be turned on and off for experimental periods to compare the effect of DBS on behaviour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID14888

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on DBS on/off

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe