Parkinson DiseaseNCT06485986
Frontosubthalamic Networks in Parkinson's Disease.
A study testing DBS on/off in people with Parkinson Disease and Impulse Control Disorder, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Impulse Control Disorder
- What is being tested?
- DBS on/off
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Oxford, OX39DU
John Eraifej, BSc MBChB MRCS, 01865222763
About this study
Official title: 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)
- Conditions
- Parkinson Disease, Impulse Control Disorder
- Being tested
- DBS on/off
- Keywords
- Deep brain stimulation
- Medical subject headings
- Parkinson Disease, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS on/offOther
DBS will be turned on and off for experimental periods to compare the effect of DBS on behaviour.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: DBS on/off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485986
- Sponsor's protocol ID
- PID14888
- Status last verified
- Mar 2025
- First submitted
- 26 Jun 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38869168Eraifej 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.
PubMed 37397890
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontosubthalamic Network Dynamics and Their Modulation During Impulse Control and Decision Making in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06485986
- Acronym / sponsor ID
- PID14888
- Conditions
- Parkinson Disease, Impulse Control Disorder
- Keywords
- Deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease DBS, no Impulse Control Disorder | Active comparator | Other: DBS on/offPatients 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. |
| Parkinson's Disease DBS, with Impulse Control Disorder | Experimental | Other: DBS on/offPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS on/offDBS will be turned on and off for experimental periods to compare the effect of DBS on behaviour. | Other | Parkinson's Disease DBS, no Impulse Control Disorder, Parkinson's Disease DBS, with Impulse Control Disorder |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 38869168Herz 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.
- Background: PubMed 37397890Eraifej 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS on/off in people with Parkinson Disease and Impulse Control Disorder, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Eraifej, BSc MBChB MRCS (01865222763, john.eraifej@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify effect of therapeutic STN-DBS on frontosubthalamic networks in PD related ICDs during decision making and impulse control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485986, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.