Parkinson Disease (PD)VIM vs NSTNCT06936254
One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease
An observational study of Parkinson Disease (PD) and Deep Brain Stimulation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study compares the effects of deep brain stimulation (DBS) of the thalamic VIM nucleus versus the subthalamic nucleus (STN) on the levodopa equivalent daily dose (LEDD) in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease (PD), Deep Brain Stimulation
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to 30 Sep 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include patients with Parkinson's disease who underwent deep brain stimulation (DBS) surgery targeting either the subthalamic nucleus (STN) or the ventral intermediate nucleus (VIM) of the thalamus at the CHRU of Nancy between 2014 (DxCare arrivals) and 2024. Eligible patients must have a diagnosis of Parkinson's disease
Who may be able to join
- Clinical diagnosis of Parkinson's disease
- Underwent surgery for subthalamic nucleus (STN) or ventral intermediate nucleus (VIM) deep brain stimulation
- Surgery performed at CHRU of Nancy
- Surgery performed between 2014 (DxCare implementation) and 2024
Who cannot join
- No clinical diagnosis of Parkinson's disease
- No initial dopaminergic treatment
- Surgery not performed at CHRU of Nancy
- Death within 1 year following surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chru Nancy
Nancy, Lorraine, 54000
Amory Jardel, +33 6 88 45 13 20, a.jardel@chru-nancy.fr
About this study
This study compares the effects of deep brain stimulation (DBS) of the thalamic VIM nucleus versus the subthalamic nucleus (STN) on the levodopa equivalent daily dose (LEDD) in patients with Parkinson's disease. The goal is to determine whether VIM stimulation, typically used for tremor, can also reduce medication needs. It hypothesizes that STN stimulation leads to greater LEDD reduction, but VIM may offer moderate benefits in selected case
Read the detailed description
Thesis Summary:
Deep brain stimulation (DBS) is a well-established therapeutic option for patients with advanced Parkinson's disease. The two most commonly targeted structures are the subthalamic nucleus (STN) and the ventral intermediate nucleus (VIM) of the thalamus. While STN stimulation is known to allow a significant reduction in the levodopa equivalent daily dose (LEDD), the effects of VIM stimulation on medication dosage remain less clear, particularly in patients selected for predominant tremor.
Objectives:
To compare the evolution of LEDD one year after DBS targeting the VIM versus the STN in patients with Parkinson's disease.
To assess whether VIM stimulation also enables a meaningful reduction in dopaminergic medication.
To contribute to refining surgical indications based on the patient's clinical profile.
Hypotheses:
STN stimulation leads to a greater reduction in LEDD compared to VIM stimulation.
VIM stimulation, though primarily used for tremor control, may result in moderate LEDD reduction in specific patient profiles.
Surgical target selection should be personalized, considering not only motor symptom control but also the impact on medication requirements.
- Conditions
- Parkinson Disease (PD), Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VIM group | Patients in this group underwent deep brain stimulation (DBS) targeting the ventral intermediate nucleus (VIM) of the thalamus. VIM stimulation is primarily used for the control of tremor in Parkinson's disease patients, particularly those with tremor-dominant symptoms. This group includes individuals who were selected for DBS due to the prominence of tremor in their clinical presentation, with less emphasis on other motor symptoms such as bradykinesia or rigidity | |
| NST group | Patients in this group underwent DBS targeting the subthalamic nucleus (STN). STN stimulation is commonly used in patients with advanced Parkinson's disease, particularly for those who experience motor fluctuations, dyskinesias, and who require a significant reduction in dopaminergic medication. This group includes patients who were selected for DBS based on their overall motor symptoms, including bradykinesia and rigidity, with or without tremor predominance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.
To compare the one-year change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.
Measured: The primary endpoint, which is the change in levodopa equivalent daily dose (LEDD), will be measured one year post-surgery in both the VIM and STN DBS groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JARDEL Amory, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936254
- Sponsor's protocol ID
- 2024PI211
- Acronym
- VIM vs NST
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06936254
- Acronym / sponsor ID
- VIM vs NST / 2024PI211
- Conditions
- Parkinson Disease (PD), Deep Brain Stimulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Apr 2025 (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.
This study compares the effects of deep brain stimulation (DBS) of the thalamic VIM nucleus versus the subthalamic nucleus (STN) on the levodopa equivalent daily dose (LEDD) in patients with Parkinson's disease. The goal is to determine whether VIM stimulation, typically used for tremor, can also reduce medication needs. It hypothesizes that STN stimulation leads to greater LEDD reduction, but VIM may offer moderate benefits in selected case
Detailed description
Thesis Summary:
Deep brain stimulation (DBS) is a well-established therapeutic option for patients with advanced Parkinson's disease. The two most commonly targeted structures are the subthalamic nucleus (STN) and the ventral intermediate nucleus (VIM) of the thalamus. While STN stimulation is known to allow a significant reduction in the levodopa equivalent daily dose (LEDD), the effects of VIM stimulation on medication dosage remain less clear, particularly in patients selected for predominant tremor.
Objectives:
To compare the evolution of LEDD one year after DBS targeting the VIM versus the STN in patients with Parkinson's disease.
To assess whether VIM stimulation also enables a meaningful reduction in dopaminergic medication.
To contribute to refining surgical indications based on the patient's clinical profile.
Hypotheses:
STN stimulation leads to a greater reduction in LEDD compared to VIM stimulation.
VIM stimulation, though primarily used for tremor control, may result in moderate LEDD reduction in specific patient profiles.
Surgical target selection should be personalized, considering not only motor symptom control but also the impact on medication requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIM group | – | –Patients in this group underwent deep brain stimulation (DBS) targeting the ventral intermediate nucleus (VIM) of the thalamus. VIM stimulation is primarily used for the control of tremor in Parkinson's disease patients, particularly those with tremor-dominant symptoms. This group includes individuals who were selected for DBS due to the prominence of tremor in their clinical presentation, with less emphasis on other motor symptoms such as bradykinesia or rigidity |
| NST group | – | –Patients in this group underwent DBS targeting the subthalamic nucleus (STN). STN stimulation is commonly used in patients with advanced Parkinson's disease, particularly for those who experience motor fluctuations, dyskinesias, and who require a significant reduction in dopaminergic medication. This group includes patients who were selected for DBS based on their overall motor symptoms, including bradykinesia and rigidity, with or without tremor predominance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include patients with Parkinson's disease who underwent deep brain stimulation (DBS) surgery targeting either the subthalamic nucleus (STN) or the ventral intermediate nucleus (VIM) of the thalamus at the CHRU of Nancy between 2014 (DxCare arrivals) and 2024. Eligible patients must have a diagnosis of Parkinson's disease
Key inclusion criteria (4 listed)
- Clinical diagnosis of Parkinson's disease
- Underwent surgery for subthalamic nucleus (STN) or ventral intermediate nucleus (VIM) deep brain stimulation
- Surgery performed at CHRU of Nancy
- Surgery performed between 2014 (DxCare implementation) and 2024
Key exclusion criteria (4 listed)
- No clinical diagnosis of Parkinson's disease
- No initial dopaminergic treatment
- Surgery not performed at CHRU of Nancy
- Death within 1 year following surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.
Time frame: The primary endpoint, which is the change in levodopa equivalent daily dose (LEDD), will be measured one year post-surgery in both the VIM and STN DBS groups.
To compare the one-year change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.
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 25 Apr 2025.
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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?
An observational study of Parkinson Disease (PD) and Deep Brain Stimulation, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 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 France. 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 Amory Jardel (+33 6 88 45 13 20, a.jardel@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN. (time frame: The primary endpoint, which is the change in levodopa equivalent daily dose (LEDD), will be measured one year post-surgery in both the VIM and STN DBS groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2025.