Frontosubthalamic Networks in Parkinson's Disease.

NCT06485986 | Recruiting

• 1 other identifier: PID14888
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Parkinson Disease; Impulse Control Disorder

Keywords

Deep brain stimulation

Outcome Measures

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.

  12 months

Study Arms (2)

Parkinson's Disease DBS, no Impulse Control Disorder

ACTIVE COMPARATOR

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

Parkinson's Disease DBS, with Impulse Control Disorder

EXPERIMENTAL

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

Interventions

DBS on/off OTHER

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

Parkinson's Disease DBS, no Impulse Control Disorder; Parkinson's Disease DBS, with Impulse Control Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, OX39DU, United Kingdom

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Central Study Contacts

John Eraifej, BSc MBChB MRCS

CONTACT

01865222763; john.eraifej@ndcn.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

GB (1)