Frontosubthalamic Networks in Parkinson's Disease.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-08-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Parkinson Disease Impulse Control Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two groups of patients will be recruited:

* Parkinson's disease patients treated with deep brain stimulation and no impulse control disorder
* Parkinson's disease patients treated with deep brain stimulation and impulse control disorder (an increase in QUIP-RS after surgery)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

DBS on/off

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

DBS on/off

Intervention Type OTHER

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

Interventions

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DBS on/off

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No